Identity
- Trade Name
- CGMS® iPro™ FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- SYSTEM MMT-7708NA CGMS IPRO V1.0 EN FDA UDI
- Model / Reference
- MMT-7708NA FDA UDI
- Description
- SYSTEM MMT-7708NA CGMS IPRO V1.0 EN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994343604 FDA UDI
- PMA Number
- P980022 FDA UDI
- FDA Product Code
- MDS FDA UDICGA FDA UDIOYC FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 862.1345 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
CGMS® iPro™ by Medtronic Minimed, 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.
- Dexcom G7 GSS (151) — Dexcom · Class II
- Dexcom G7 AR Overlay 10-Pack — Dexcom · Class I
- Stelo Glucose Biosensor (1pk) — Dexcom · Class II
- Dexcom G7 GSS (155) — Dexcom · Class II
- Dexcom Discovery Sensor 1 Pack — Dexcom · Class II
- Bigfoot Unity Diabetes Management System — BIGFOOT BIOMEDICAL, INC. · Class II
- Dexcom G7 Receiver — Dexcom · Class II
- Bigfoot Unity Diabetes Management System — BIGFOOT BIOMEDICAL, INC. · Class II
Cleared under the same submission
P980022 also covers:
- GUARDIAN® — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Minimed, Inc.
Sources (1)
- FDA UDI 220a185d-400f-4f6f-b0d1-dd985492f1a0 35 fields · synced Jun 8, 2026