Ampere™ H700492
GUDID 05415067004925
ST. JUDE MEDICAL, INC.
Radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Percutaneous radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator Cardiac radio-frequency ablation system generator| Primary Device ID | 05415067004925 |
| NIH Device Record Key | d21b8d32-322a-4a14-8534-b71e31710857 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ampere™ |
| Version Model Number | H700492 |
| Catalog Number | H700492 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -25 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067004925 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P110016
FDA Product Code
| LPB | Cardiac ablation percutaneous catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-28 |
| Device Publish Date | 2014-12-03 |
On-Brand Devices [Ampere™]
| 05415067005045 | Generator Accessories |
| 05415067005014 | Footswitch |
| 05415067005007 | Footswitch |
| 05415067004994 | Footswitch |
| 05415067004987 | Footswitch |
| 05415067004949 | H700494 |
| 05415067004925 | H700492 |
| 05415067004901 | Remote Control |
| 05415067004888 | H700488 |
| 05415067013392 | Fiber Cord Assembly Remote |
| 05415067013385 | Fiber Cord Assembly Remote |
| 05415067013378 | Fiber Cord Assembly Remote |
Trademark Results [Ampere]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMPERE 97826428 not registered Live/Pending |
Xianhui Xiao 2023-03-07 |
 AMPERE 97811344 not registered Live/Pending |
ALPHAROC INC. 2023-02-24 |
 AMPERE 97134252 not registered Live/Pending |
MPS North America 2021-11-19 |
 AMPERE 88168089 not registered Live/Pending |
Gogotoro LLC 2018-10-24 |
 AMPERE 87980846 not registered Live/Pending |
AMPERE COMPUTING LLC 2017-11-13 |
 AMPERE 87937039 not registered Dead/Abandoned |
Ampere LLC 2018-05-25 |
 AMPERE 87719157 not registered Dead/Abandoned |
Ampere Computing LLC 2017-12-13 |
 AMPERE 87681720 not registered Live/Pending |
AMPERE COMPUTING LLC 2017-11-13 |
 AMPERE 87679932 not registered Dead/Abandoned |
SPIGEN, INC. 2017-11-10 |
 AMPERE 87642617 5469256 Live/Registered |
CHAN, ANTHONY WAN SHAN 2017-10-12 |
 AMPERE 86652698 5223737 Live/Registered |
Ampere Analysis Limited 2015-06-05 |
 AMPERE 86410990 not registered Dead/Abandoned |
Tin Whiskers Brewing Co., LLC 2014-09-30 |
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