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PARADIGM® REAL-time

FDA UDI

Class III (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name
PARADIGM® REAL-time FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic, non-software-dosing FDA UDI
Device Name
PUMP MMT-522KNB PRDGM PED INS V1.1 BL EN FDA UDI
Model / Reference
MMT-522KNB FDA UDI
Description
PUMP MMT-522KNB PRDGM PED INS V1.1 BL EN FDA UDI

Identifiers

Primary DI / UDI-DI
00613994373168 FDA UDI
PMA Number
P980022 FDA UDI
FDA Product Code
MDS FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic, non-software-dosing 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

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® REAL-time by Medtronic Minimed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

P980022 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 9df25254-d90a-41ac-bf59-4f433c2a5ef8 36 fields · synced May 30, 2026