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Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Endoscope working-channel valve, single-use FDA UDI
Device Name
This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow of air. Do not use this product for any other purpose. FDA UDI
Model / Reference
FV-003 FDA UDI
Description
This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow of air. Do not use this product for any other purpose. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410480993 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Endoscope working-channel valve, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope working-channel valve, single-use

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

Similar devices

Also classified as Endoscope working-channel valve, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 3d44daa3-5825-4f0e-9d67-77043447ee04 35 fields · synced May 30, 2026