GUDIDData
pma Primary ID: P120010

Enlite Sensor (MMT-7008) (UDI P120010)

Manufactured by Medtronic, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Enlite Sensor (MMT-7008) - Primary ID P120010

Device Regulatory Overview

The Enlite Sensor (MMT-7008) (Model/Catalog Number: Unspecified) is a medical device manufactured by Medtronic, Inc.. This product is indexed under FDA Product Code / Category Classification OZO within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0726-2026 View Full Alert →

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🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2168-2025 View Full Alert →

Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1.Cobalt Crome application, So...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-2128-2025 View Full Alert →

Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1.A...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
N/A
Product Code / EMDN
OZO
Device Name
Automated insulin dosing , threshold suspend
Database Sync Date
2026-08-09 10:04:57

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Enlite Sensor (MMT-7008)?

The registered manufacturer of record for Enlite Sensor (MMT-7008) is Medtronic, Inc..

What is the Primary UDI-DI identifier for Enlite Sensor (MMT-7008)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P120010.

What classification code is assigned to this device?

This device is registered under product classification code OZO.

Programmatic Export

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