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Paradigm® REAL-Time Revel™

FDA UDI

Class III (US FDA UDI)

by Medtronic Minimed, Inc.

Identity

Trade Name
Paradigm® REAL-Time Revel™ FDA UDI
Generic Name
Ambulatory insulin infusion pump, electronic, non-software-dosing FDA UDI
Device Name
PUMP MMT-523NAP PRDGM V2.5B PL US PR FDA UDI
Model / Reference
MMT-523NAP FDA UDI
Description
PUMP MMT-523NAP PRDGM V2.5B PL US PR FDA UDI

Identifiers

Primary DI / UDI-DI
00643169446410 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

The Paradigm REAL-Time Revel pump is a portable, continuous or intermittent subcutaneous insulin delivery device designed to provide precise and reliable insulin dosing. It features a durable design, easy-to-use interface, and advanced sensors for real-time monitoring of glucose levels.

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 175f310f-4408-4f27-b9dc-bba68a3bf7d4 36 fields · synced Oct 7, 2026