InCheck™ AT PATIENT ASSISTANT
- Primary DI
- 00721902825569
- Brand
- InCheck™ AT PATIENT ASSISTANT
- Company
- MEDTRONIC, INC.
- Model
- 9465AA
- Device description
- ACTIVATOR 9465AA PATIENT ACTIVATOR US
- Published
- 2014-09-23
- 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 |
|---|
| 00721902825569 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00721902825569 | 00721902825569 | 721902825569 | 0721902825569 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac pulse generator reader, home-use | An external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. This is a home-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -40 Degrees Fahrenheit | 150 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
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