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Paradigm®

FDA UDI

Class II (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name
Paradigm® FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic, non-software-dosing FDA UDI
Device Name
PUMP MMT-715LNAS ROHS PRDGM 2.3 SK EN LN FDA UDI
Model / Reference
MMT-715LNAS FDA UDI
Description
PUMP MMT-715LNAS ROHS PRDGM 2.3 SK EN LN FDA UDI

Identifiers

Primary DI / UDI-DI
00763000423117 FDA UDI
510(k) Number
K040676 FDA UDI
FDA Product Code
LZG FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic, non-software-dosing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory insulin infusion pump, electronic, non-software-dosing

Paradigm® by Medtronic Minimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ambulatory insulin infusion pump, electronic, non-software-dosing.

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 16d16b6d-baa6-4a4c-a881-7312324cf37e 35 fields · synced Jun 8, 2026