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Fujifilm

FDA UDI

Class I (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 facilityes and attached to our endoscope to prevent air leak or backflow of body fluid from the forceps inlet. Do not use this product for any other purpose. FDA UDI
Model / Reference
FOV-LL2 FDA UDI
Description
This product is used in medical facilityes and attached to our endoscope to prevent air leak or backflow of body fluid from the forceps inlet. Do not use this product for any other purpose. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410079357 FDA UDI
FDA Product Code
FFY FDA UDI
GMDN Term
Endoscope working-channel valve, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope working-channel valve, single-use

Fujifilm by FUJIFILM Corporation — Class I — 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 3ef89e5e-23aa-427c-90ac-adf7fbbe75fc 35 fields · synced May 31, 2026