SJM CONFIRM™ DM2100
GUDID 05414734502597
Implantable Cardiac Monitor
ST. JUDE MEDICAL, INC.
Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor| Primary Device ID | 05414734502597 |
| NIH Device Record Key | 59bc934f-35e1-46fa-adbc-b47e514c5b5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM CONFIRM™ |
| Version Model Number | DM2100 |
| Catalog Number | DM2100 |
| Company DUNS | 790268031 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device in a clean area. |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734502597 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| MXC | RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-02-03 |
On-Brand Devices [SJM CONFIRM™]
| 05414734502696 | External Patient Activator |
| 05414734502597 | Implantable Cardiac Monitor |
| 05414734502573 | Implantable Cardiac Monitor with AF detection |
Trademark Results [SJM CONFIRM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SJM CONFIRM 77395224 3620474 Live/Registered |
Pacesetter, Inc. 2008-02-12 |
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