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Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Device Name
The balloon is intended to be used in combination with Double Balloon Endoscopes to assist with insertion inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children. FDA UDI
Model / Reference
BS-2 FDA UDI
Description
The balloon is intended to be used in combination with Double Balloon Endoscopes to assist with insertion inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410331370 FDA UDI
510(k) Number
K040048 FDA UDI
FDA Product Code
KNT FDA UDI
FDA FDA UDI
GMDN Term
Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated

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

Similar devices

Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.

Cleared under the same submission

K040048 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 2e44987e-1da7-4ca6-bb86-7cee29f2ee14 36 fields · synced May 30, 2026