Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Luminal device flushing tubing set, reusable FDA UDI
Device Name: This product is the cleaning adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose. FDA UDI
Model / Reference: CA-601 FDA UDI
Description: This product is the cleaning adapter used in combination with our endoscopes in medical facilities. Do not use this product for any other purpose. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410138511 FDA UDI
510(k) Number: K120446 FDA UDI
FDA Product Code: ITX FDA UDI
FDS FDA UDI
GMDN Term: Luminal device flushing tubing set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Luminal device flushing tubing set, reusable

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

Similar devices

Also classified as Luminal device flushing tubing set, reusable.

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CONNECTING TUBE — Olympus Medical Systems Corporation · Class II
Medivators Hookup — MEDIVATORS INC. · Class II
Medivators Hookup — MEDIVATORS INC. · Class II
Medivators Hookup — MEDIVATORS INC. · Class II
Suction cleaning adaptor — Olympus Medical Systems Corporation · Class II
Medivators Hookup — MEDIVATORS INC. · Class II
Water-resistant cap — Olympus Medical Systems Corporation · Class II

Cleared under the same submission

K120446 also covers:

FUJIFILM — FUJIFILM Corporation
FUJIFILM — FUJIFILM Corporation

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 4cf5a5ef-685c-473c-bdc4-63f649788d9e 36 fields · synced Jun 8, 2026