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Enlite ®

FDA UDI

Class III (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name
Enlite ® FDA UDI
Generic Name
Percutaneous interstitial fluid glucose monitoring system sensor FDA UDI
Device Name
SENSOR MMT-7008A ENLT PLUS 5PK 2L 1CL PR FDA UDI
Model / Reference
MMT-7008A FDA UDI
Description
SENSOR MMT-7008A ENLT PLUS 5PK 2L 1CL PR FDA UDI

Identifiers

Primary DI / UDI-DI
20643169786725 FDA UDI
PMA Number
P120010 FDA UDI
P150001 FDA UDI
P150019 FDA UDI
P150029 FDA UDI
P160017 FDA UDI
FDA Product Code
OZO 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

Category: Percutaneous interstitial fluid glucose monitoring system sensor

Enlite ® 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

P120010 also covers:

P150001 also covers:

P150019 also covers:

P150029 also covers:

P160017 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 b5344100-76f1-4351-a48f-097a5edef1f9 36 fields · synced Jun 8, 2026