Identity
- Trade Name
- Guardian™ Sensor (3) FDA UDI
- Generic Name
- Percutaneous interstitial fluid glucose monitoring system sensor FDA UDI
- Device Name
- SENSOR MMT-7020LB GS3 1PK US FDA UDI
- Model / Reference
- MMT-7020LB FDA UDI
- Description
- SENSOR MMT-7020LB GS3 1PK US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000336998 FDA UDI
- PMA Number
- P160017 FDA UDI
- FDA Product Code
- OZP FDA UDI
- GMDN Term
- Percutaneous interstitial fluid glucose monitoring system sensor 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
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 sensor
Guardian™ Sensor (3) 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 sensor.
- Guardian™ 4 — MEDTRONIC MINIMED, INC. · Class III
- ENLITE® — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Sensor (3) — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Sensor (3) — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Sensor (3) — MEDTRONIC MINIMED, INC. · Class III
- Medtronic Simplera™ Sensor — MEDTRONIC MINIMED, INC. · Class III
- Guardian™ Sensor (3) — MEDTRONIC MINIMED, INC. · Class III
- Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC. · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Minimed, Inc.
Sources (1)
- FDA UDI f43b377b-c51d-430b-88b9-26dd2a56a38d 36 fields · synced May 30, 2026