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Medtronic Simplera™ Sensor

FDA UDI

Class III (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name
Medtronic Simplera™ Sensor FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system sensor FDA UDI
Device Name
KIT MMT-5101N SIMPLERA 5PK US FDA UDI
Model / Reference
MMT-5101N FDA UDI
Description
KIT MMT-5101N SIMPLERA 5PK US FDA UDI

Identifiers

Primary DI / UDI-DI
20763000565040 FDA UDI
PMA Number
P160007 FDA UDI
FDA Product Code
PQF 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

Yes

FDA UDI

Single Use

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Percutaneous interstitial fluid glucose monitoring system sensor

Medtronic Simplera™ Sensor 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.

Cleared under the same submission

P160007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Minimed, Inc.

Sources (1)

  • FDA UDI b382629c-95b9-4d24-bf9e-59ec88395944 36 fields · synced Jun 8, 2026