Cobalt™ VR MRI SureScan™
- Primary DI
- 00763000178499
- Brand
- Cobalt™ VR MRI SureScan™
- Company
- MEDTRONIC, INC.
- Model
- DVPB3D1
- Device description
- ICD DVPB3D1 COBALT VR MRI DF1
- Published
- 2020-06-08
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Unknown | 3 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00763000178499 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00763000178499 | 00763000178499 | 763000178499 | 0763000178499 |
GMDN Terms
| Term | Definition |
|---|
| Single-chamber implantable defibrillator | An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD). |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 0 Degrees Fahrenheit | 131 Degrees Fahrenheit | |
Regulatory Flags
- DUNS number
- 006261481
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 05414734500586 | NA | ST. JUDE MEDICAL, INC. | LWS | 2025-05-07 |
| 00763000180010 | Sprint Quattro Secure S™ | MEDTRONIC, INC. | LWS | 2024-11-04 |
| 00763000180058 | Sprint Quattro Secure S MRI™ SureScan™ | MEDTRONIC, INC. | LWS | 2024-11-04 |
| 00802526623400 | NA | BOSTON SCIENTIFIC CORPORATION | LWS | 2024-08-29 |
| 05415067049414 | Entrant™ | ST. JUDE MEDICAL, INC. | LWS | 2024-04-25 |
| 05415067049421 | Gallant™ | ST. JUDE MEDICAL, INC. | LWS | 2024-04-25 |
| 05415067049469 | Entrant™ | ST. JUDE MEDICAL, INC. | LWS | 2024-04-25 |
| 05415067049476 | Gallant™ | ST. JUDE MEDICAL, INC. | LWS | 2024-04-25 |
| 00763000369743 | Epsila EV™ | MEDTRONIC, INC. | LWS | 2023-11-03 |
| 00763000368470 | Aurora EV-ICD™ MRI SureScan™ | MEDTRONIC, INC. | LWS | 2023-11-02 |
| 00763000369767 | Epsila EV™ MRI SureScan™ | MEDTRONIC, INC. | LWS | 2023-11-02 |
| 00763000571528 | NA | MEDTRONIC, INC. | LWS | 2023-07-30 |
| 05415067037121 | Merlin™ | ST. JUDE MEDICAL, INC. | LWS | 2022-08-29 |
| 00802526615108 | EMBLEM™ S-ICD Programmer | BOSTON SCIENTIFIC CORPORATION | LWS | 2022-01-26 |
| 00802526588280 | RESONATE™ HF ICD VR | BOSTON SCIENTIFIC CORPORATION | LWS | 2021-07-12 |
| 00802526588310 | RESONATE™ HF ICD DR | BOSTON SCIENTIFIC CORPORATION | LWS | 2021-07-12 |
| 05415067032812 | myMerlinPulse™ | ST. JUDE MEDICAL, INC. | LWS | 2021-01-07 |
| 00763000178338 | Cobalt™ XT DR MRI SureScan™ | MEDTRONIC, INC. | LWS | 2020-11-22 |
| 00763000178345 | Cobalt™ XT DR MRI SureScan™ | MEDTRONIC, INC. | LWS | 2020-11-22 |
| 00763000178451 | Cobalt™ XT VR MRI SureScan™ | MEDTRONIC, INC. | LWS | 2020-11-22 |
| 00763000178468 | Cobalt™ XT VR MRI SureScan™ | MEDTRONIC, INC. | LWS | 2020-11-22 |
| 00643169720589 | Evera MRI™ S VR SureScan® | MEDTRONIC, INC. | LWS | 2020-11-13 |
| 00643169837751 | Evera MRI™ XT VR SureScan™ | MEDTRONIC, INC. | LWS | 2020-11-13 |
| 00763000060060 | Visia AF MRI™ S VR SureScan™ | MEDTRONIC, INC. | LWS | 2020-09-04 |
| 05415067031990 | Gallant™ | ST. JUDE MEDICAL, INC. | LWS | 2020-09-02 |
| 05415067032836 | Entrant™ | ST. JUDE MEDICAL, INC. | LWS | 2020-09-02 |
| 00763000178390 | Cobalt™ DR MRI SureScan™ | MEDTRONIC, INC. | LWS | 2020-06-08 |
| 00802526611322 | ZOOM® LATITUDE® | BOSTON SCIENTIFIC CORPORATION | LWS | 2019-11-07 |
| 00802526610516 | EMBLEM™ S-ICD Programmer | BOSTON SCIENTIFIC CORPORATION | LWS | 2019-11-06 |
| 04035479156756 | Ilivia Neo 7 VR-T DX | BIOTRONIK SE & Co. KG | LWS | 2019-09-10 |
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