Identity
- Trade Name
- CareLink® FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- SOFTWARE MMT-7335 V1.3 CARELINK PRO EN FDA UDI
- Model / Reference
- MMT-7335 FDA UDI
- Description
- SOFTWARE MMT-7335 V1.3 CARELINK PRO EN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994605443 FDA UDI
- PMA Number
- P980022 FDA UDI
- FDA Product Code
- MDS FDA UDI
- GMDN Term
- Patient health record information system application software 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient health record information system application software
CareLink® by Medtronic Minimed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P980022 also covers:
- CGMS® iPro™ — MEDTRONIC MINIMED, INC.
- GUARDIAN® — MEDTRONIC MINIMED, INC.
- MiniLink® — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, INC.
- PARADIGM® REAL-time — MEDTRONIC MINIMED, 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 Minimed, Inc.
Sources (1)
- FDA UDI 936f4e3d-962f-489e-840d-b277e777b623 35 fields · synced Jun 8, 2026