Wi-Fi™
- Primary DI
- 05414734506830
- Brand
- Wi-Fi™
- Company
- ST. JUDE MEDICAL, INC.
- Model
- EX3213
- Catalog number
- EX3213
- Device description
- Wi-Fi™ Card
- Published
- 2016-10-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- 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 |
|---|
| 05414734506830 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05414734506830 | 05414734506830 | 5414734506830 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac pulse generator software | An application or operating data program (i.e., primarily operating system software that may include some application program functionality) designed for use in or with an implantable cardioverter-defibrillator (ICD) and an implantable cardiac pacemaker so that the defibrillator and pacemaker function according to their intended purpose. This software program may be permanently installed or exchanged as an upgrade. |
Regulatory Flags
- DUNS number
- 790268031
- 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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| 00763000178451 | Cobalt™ XT VR MRI SureScan™ | MEDTRONIC, INC. | LWS | 2020-11-22 |
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| 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 |