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RemunityPRO

FDA UDI

Class II (US FDA UDI)

by United Therapeutics Corporation

Identity

Trade Name
RemunityPRO FDA UDI
Generic Name
Ambulatory non-insulin infusion pump, electronic FDA UDI
Device Name
RemunityPRO Starter Kit contains 2 pumps, 2 remote interfaces, chargers, batteries, and Instructions for Use. Required to initiate treatment with the system. FDA UDI
Model / Reference
DKUT-11029-007 FDA UDI
Description
RemunityPRO Starter Kit contains 2 pumps, 2 remote interfaces, chargers, batteries, and Instructions for Use. Required to initiate treatment with the system. FDA UDI

Identifiers

Primary DI / UDI-DI
00850017421233 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Ambulatory non-insulin infusion pump, electronic 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

Yes

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 non-insulin infusion pump, electronic

RemunityPRO by United Therapeutics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
United Therapeutics Corporation

Sources (1)

  • FDA UDI 7d6d63ab-6189-4612-b428-b9fdea6e2a08 35 fields · synced May 30, 2026