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EndoFLIP

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
EndoFLIP FDA UDI
Generic Name
Manometric gastrointestinal motility analysis system FDA UDI
Device Name
ENDO CATHETER EF-325N 8CM NASAL TIP FDA UDI
Model / Reference
EF-325N FDA UDI
Description
ENDO CATHETER EF-325N 8CM NASAL TIP FDA UDI

Identifiers

Primary DI / UDI-DI
05391530810005 FDA UDI
FDA Product Code
FFX FDA UDI
GMDN Term
Manometric gastrointestinal motility analysis system 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

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

No

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

Category: Manometric gastrointestinal motility analysis systemGastrointestinal barostat

EndoFLIP 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 521abb15-015c-4000-bf33-ab3c806db046 35 fields · synced May 30, 2026