Identity
- Trade Name
- Tester FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- PLUG MMT-7736L TEST LOCKOUT IIN EU MDR FDA UDI
- Model / Reference
- MMT-7736L FDA UDI
- Description
- PLUG MMT-7736L TEST LOCKOUT IIN EU MDR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000348021 FDA UDI
- PMA Number
- P160007 FDA UDI
- FDA Product Code
- OZP 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
Yes
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: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Tester 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
P160007 also covers:
- Charger — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — MEDTRONIC MINIMED, INC.
- Guardian™ Connect App — 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 b0e41335-4f8d-4af2-bce2-c778489b1f91 36 fields · synced May 30, 2026