| Primary Device ID | 15414734400746 |
| NIH Device Record Key | 4e7021e3-4bc2-4127-adb1-f039a0170af7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tennafix™ |
| Version Model Number | 1205 |
| Catalog Number | 1205 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734400749 [Primary] |
| GS1 | 15414734400746 [Package] Contains: 05414734400749 Package: [100 Units] Discontinued: 2016-11-11 Not in Commercial Distribution |
| GS1 | 25414734400743 [Package] Contains: 05414734400749 Package: [20 Units] In Commercial Distribution |
| GS1 | 35414734400740 [Package] Contains: 25414734400743 Package: [5 Units] In Commercial Distribution |
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-09-08 |
| 05415067050045 - Neutrino™ | 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
| 05415067050052 - Gallant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
| 05415067050076 - Neutrino™ | 2025-02-19 NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
| 05415067050090 - Gallant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
| 05415067050106 - Entrant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
| 05415067050120 - Entrant™ | 2025-02-19 HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV |
| 05415067051844 - Agilis™ NxT Steerable Introducer Dual-Reach™ | 2025-02-17 Steerable Introducer |
| 05415067051851 - Agilis™ NxT Steerable Introducer Dual-Reach™ | 2025-02-17 Steerable Introducer |