Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Gastrointestinal endoscopic insufflator FDA UDI
Device Name: This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system. FDA UDI
Model / Reference: GW-100 FDA UDI
Description: This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410331592 FDA UDI
510(k) Number: K133976 FDA UDI
K180711 FDA UDI
FDA Product Code: FCX FDA UDI
GMDN Term: Gastrointestinal endoscopic insufflator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal endoscopic insufflator

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal endoscopic insufflator.

CO2EFFICIENT — US Endoscopy · Class II
Protocol Colon Insufflator Demo Unit — Bracco Diagnostics Inc. · Class II
Two Tank Shuttle Valve System — Bracco Diagnostics Inc. · Class II
ENDOSCOPIC CO2 REGULATION UNIT — Olympus Medical Systems Corporation · Class II
Protocol Colon Insufflator — Bracco Diagnostics Inc. · Class II
Erbe ECO2 plus — PALLIARE INC · Class II
ENDO STRATUS CO2 Insufflator — MEDIVATORS INC. · Class II
IRRIGATOR/INSUFFLATOR — PENTAX of America, Inc. · Class II

Cleared under the same submission

K133976 also covers:

FUJIFILM — FUJIFILM Corporation
FUJIFILM — FUJIFILM Corporation

K180711 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: FUJIFILM Corporation

Sources (1)

FDA UDI 1ff8f473-7747-493a-a961-27b82e461271 36 fields · synced May 31, 2026