Identity
- Trade Name
- Tester FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
- Device Name
- Tester EUDAMEDPLUG MMT-7736L TEST LOCKOUT 2PK EN FDA UDI
- Model / Reference
- MMT-7736WW EUDAMEDMMT-7736L FDA UDI
- Description
- PLUG MMT-7736L TEST LOCKOUT 2PK EN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000348014 EUDAMED20643169975105 FDA UDI
- Basic UDI-DI
- 0763000B00000346X EUDAMED
- PMA Number
- P160017 FDA UDI
- FDA Product Code
- OZP FDA UDI
- EMDN Code
- Z12040180 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system, electrochemical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical
Tester by Medtronic Minimed, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Unknown |
| 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 edac7ceb-043c-40fc-bc16-3f735a96063e 36 fields · synced Oct 6, 2026
- EUDAMED 6ee55bc1-de0a-4e6b-ba69-6f0a08748e26 61 fields · synced Jul 14, 2026