Identity
- Trade Name
- iPro™2 FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- RCDR MMT-7741 IPRO2 V1.1 RPL 27L FDA UDI
- Model / Reference
- MMT-7741 FDA UDI
- Description
- RCDR MMT-7741 IPRO2 V1.1 RPL 27L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169119949 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
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
MR Unsafe FDA UDI
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
iPro™2 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 ea705de8-cc8e-46dd-b114-4f28eb3a4671 36 fields · synced Jun 1, 2026