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EndoFLIP Loaner Unit

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
EndoFLIP Loaner Unit FDA UDI
Generic Name
Gastrointestinal barostat FDA UDI
Device Name
EndoFLIP System FDA UDI
Model / Reference
RFG-EF100 FDA UDI
Description
EndoFLIP System FDA UDI

Identifiers

Primary DI / UDI-DI
05391530810166 FDA UDI
FDA Product Code
FFX FDA UDI
GMDN Term
Gastrointestinal barostat FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 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: Manometric gastrointestinal motility analysis systemGastrointestinal barostat

EndoFLIP Loaner Unit by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal barostat.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 099f01d4-3282-447e-994a-b304a5a1387a 35 fields · synced Jun 8, 2026