Identity
- Trade Name
- Guardian™ Link (3) FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- KIT MMT-7810NA ASSY PKG IIN AG FDA UDI
- Model / Reference
- MMT-7810NA FDA UDI
- Description
- KIT MMT-7810NA ASSY PKG IIN AG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000391041 FDA UDI
- PMA Number
- P160017 FDA UDI
- FDA Product Code
- OZP FDA UDIOZO 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
Guardian™ Link (3) by Medtronic Xomed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous interstitial fluid glucose monitoring system, electrochemical.
- Simplera Sync™ — MEDTRONIC MINIMED, INC. · Class III
- Dexcom G7 GSS (151) — Dexcom · Class II
- Simplera Sync™ — MEDTRONIC MINIMED, INC. · Class III
- Dexcom G7 AR Overlay 10-Pack — Dexcom · Class I
- Stelo Glucose Biosensor (1pk) — Dexcom · Class II
- Guardian™ Transmitter Kit — MEDTRONIC MINIMED, INC. · Class III
- MiniLink® — MEDTRONIC MINIMED, INC. · Class III
- Dexcom G7 GSS (155) — Dexcom · Class II
Cleared under the same submission
P160017 also covers:
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.
- CONTOUR® NEXT LINK 2.4 — ASCENSIA DIABETES CARE US INC.
- Enlite ® — MEDTRONIC MINIMED, INC.
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.
- Guardian™ 4 — MEDTRONIC MINIMED, INC.
- Guardian™ 4 — MEDTRONIC MINIMED, INC.
- Guardian™ 4 Transmitter — 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 Xomed, Inc.
Sources (1)
- FDA UDI 61172a0d-387f-4194-99a3-360eff4a8a9b 36 fields · synced Jun 8, 2026