Identity
- Trade Name
- InCheck™ Patient Assistant FDA UDI
- Generic Name
- Cardiac pulse generator reader, home-use FDA UDI
- Device Name
- ACTIVATOR 2696 PAT ASSIST 5L USM-R FDA UDI
- Model / Reference
- 2696 FDA UDI
- Description
- ACTIVATOR 2696 PAT ASSIST 5L USM-R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885074042466 FDA UDI
- PMA Number
- P980035 FDA UDI
- FDA Product Code
- NVZ FDA UDI
- GMDN Term
- Cardiac pulse generator reader, home-use FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac pulse generator reader, home-use
InCheck™ Patient Assistant by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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P980035 also covers:
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- Adapta™ — MEDTRONIC, INC.
- Adapta™ — MEDTRONIC, INC.
- Adapta™ S — MEDTRONIC, INC.
- Advisa DR MRI™ SureScan® — MEDTRONIC, INC.
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- Attesta™ DR MRI SureScan™ — MEDTRONIC, INC.
- Attesta™ L DR MRI SureScan™ — MEDTRONIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI cb33df37-51d9-4e73-9fcc-2899db3b563f 36 fields · synced May 30, 2026