← Back to catalogue

Remunity

FDA UDI

Class II (US FDA UDI)

by United Therapeutics Corporation

Identity

Trade Name
Remunity FDA UDI
Generic Name
Ambulatory non-insulin infusion pump, electronic FDA UDI
Device Name
OVER PACK, DISPOSABLE KIT, UNITY 00850017421073 package contains: 10 packs of 12ea. disposable reservoirs FDA UDI
Model / Reference
DKPI-11036-001 FDA UDI
Description
OVER PACK, DISPOSABLE KIT, UNITY 00850017421073 package contains: 10 packs of 12ea. disposable reservoirs FDA UDI

Identifiers

Primary DI / UDI-DI
00850017421073 FDA UDI
FDA Product Code
QJY 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ambulatory non-insulin infusion pump, electronic

Remunity 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
United Therapeutics Corporation

Sources (1)

  • FDA UDI 0991688e-f3a3-494f-96c2-8684d69b2fcf 35 fields · synced May 31, 2026