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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 FDA UDI
Device Name
PUMP MMT-523KLNB PRDGM PED V2.5 BL EN LN FDA UDI
Model / Reference
MMT-523KLNB FDA UDI
Description
PUMP MMT-523KLNB PRDGM PED V2.5 BL EN LN FDA UDI

Identifiers

Primary DI / UDI-DI
00643169162648 FDA UDI
PMA Number
P980022 FDA UDI
FDA Product Code
MDS FDA UDI
GMDN Term
Ambulatory insulin infusion pump, electronic FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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

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

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 99f75e64-54f5-4b99-8d68-c6d07bbaf499 37 fields · synced Jun 8, 2026