Identity
- Trade Name
- MiniLink® FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- XMTR MMT-7707NA MLNK KIT V1.3 US SGN1 FDA UDIXMTR MMT-7707NA MLNK KIT V1.1 EN FDA UDI
- Model / Reference
- MMT-7707NA FDA UDI
- Description
- XMTR MMT-7707NA MLNK KIT V1.3 US SGN1 FDA UDIXMTR MMT-7707NA MLNK KIT V1.1 EN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169278646 FDA UDI00613994574374 FDA UDI
- PMA Number
- P980022 FDA UDI
- FDA Product Code
- MDS FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical 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
Yes
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
MR Unsafe FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
MiniLink® by Medtronic Minimed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
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Cleared under the same submission
P980022 also covers:
- CGMS® iPro™ — MEDTRONIC MINIMED, INC.
- GUARDIAN® — MEDTRONIC MINIMED, INC.
- GUARDIAN® — 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 (2)
- FDA UDI 3914f0bf-c690-4bf7-9421-265e3fa7fa9d 36 fields · synced Jun 1, 2026
- FDA UDI 79b32079-b30e-4e75-a85d-87030867248a 36 fields · synced May 27, 2026