CareLink® Network
- Primary DI
- 00643169731004
- Brand
- CareLink® Network
- Company
- MEDTRONIC, INC.
- Model
- CLN07
- Device description
- SW CLN07 CARELINK NETWORK RELEASE
- Published
- 2016-04-04
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
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 |
|---|
| 00643169731004 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00643169731004 | 00643169731004 | 643169731004 | 0643169731004 |
GMDN Terms
| Term | Definition |
|---|
| Implantable cardiac device management application software | An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: device programming; device function analysis; data extraction, storage, analysis and/or transfer; and clinical consultation/intervention planning. Depending on the functionality, it can run on dedicated hardware, an off-the-shelf computer (e.g., tablet, smartphone), or web-based servers. |
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
- true
- Serial number
- false
- 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
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| 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 |
| 00763000178499 | Cobalt™ VR 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 |