Endoscopic Co2 Regulation Unit

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name: ENDOSCOPIC CO2 REGULATION UNIT FDA UDI
Generic Name: Gastrointestinal endoscopic insufflator FDA UDI
Device Name: "UCR ENDOSCOPIC CO2 REGULATION UNIT" FDA UDI
Model / Reference: OLYMPUS UCR FDA UDI
Description: "UCR ENDOSCOPIC CO2 REGULATION UNIT" FDA UDI

Identifiers

Primary DI / UDI-DI: 04953170239113 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

Endoscopic Co2 Regulation Unit by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Olympus Medical Systems Corporation

Sources (1)

FDA UDI c0387d84-1555-4ad7-a60c-02c9accb425b 34 fields · synced Jun 6, 2026