Agilis HisPro™ DS3A001
GUDID 05415067035028
Slitter
ST. JUDE MEDICAL, INC.
Intravascular catheter slitter| Primary Device ID | 05415067035028 |
| NIH Device Record Key | 95d654b5-f457-4224-8fc1-a837ab272493 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Agilis HisPro™ |
| Version Model Number | DS3A001 |
| Catalog Number | DS3A001 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry, Keep away from sunlight, Store at room temperature 20°C, 68°F |
| Handling Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067035028 [Primary] |
FDA Product Code
| DQY | Catheter, percutaneous |
| DWS | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
[05415067035028]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-01 |
| Device Publish Date | 2021-06-23 |
On-Brand Devices [Agilis HisPro™]
| 05415067032287 | Steerable Catheter with Electrodes |
| 05415067035028 | Slitter |
Trademark Results [Agilis HisPro]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AGILIS HISPRO 88375824 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2019-04-08 |
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