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Fujifilm

FDA UDI

Class I (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Endoscope flushing adaptor, reusable FDA UDI
Device Name
This product is intended to supply air or water from the water tank to the air channel of the air channel during pre-cleaning of a FIJIFILM endoscope in medical facilities. Do not use this product for any other purpose. FDA UDI
Model / Reference
CA-611 FDA UDI
Description
This product is intended to supply air or water from the water tank to the air channel of the air channel during pre-cleaning of a FIJIFILM endoscope in medical facilities. Do not use this product for any other purpose. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410297386 FDA UDI
FDA Product Code
FFY FDA UDI
GMDN Term
Endoscope flushing adaptor, reusable 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

No

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 flushing adaptor, reusable

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

Similar devices

Also classified as Endoscope flushing adaptor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 48da72c3-dce5-4012-b209-076d2307489d 35 fields · synced May 30, 2026