Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Flexible ultrasound bronchoscope FDA UDI
Device Name: This product is used for keeping the air tightness of the forceps channel valve of the endoscope. Do not use this product for any other purpose. FDA UDI
Model / Reference: FOV-BU1 FDA UDI
Description: This product is used for keeping the air tightness of the forceps channel valve of the endoscope. Do not use this product for any other purpose. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410111392 FDA UDI
510(k) Number: K121035 FDA UDI
FDA Product Code: ITX FDA UDI
EOQ FDA UDI
GMDN Term: Flexible ultrasound bronchoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
874.4680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Flexible ultrasound bronchoscope

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

Similar devices

Also classified as Flexible ultrasound bronchoscope.

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PENTAX Medical — HOYA CORPORATION · Class II
EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
PENTAX Medical — HOYA CORPORATION · Class II
ULTRASOUND BRONCHOSCOPE — PENTAX of America, Inc. · Class II
FUJIFILM — FUJIFILM Corporation · Class I
FUJIFILM — FUJIFILM Corporation · Class I
FUJIFILM — FUJIFILM Corporation · Class II

Cleared under the same submission

K121035 also covers:

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 428470b7-550f-4cea-898c-6ad31328d96d 36 fields · synced May 31, 2026