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Bib®

FDA UDI

Class II (US FDA UDI)

by B Braun Interventional Systems, Inc

Identity

Trade Name
BIB® FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
BB019 BIB Catheter 16 5.5 9F FDA UDI
Model / Reference
614429 FDA UDI
Description
BB019 BIB Catheter 16 5.5 9F FDA UDI

Identifiers

Catalog Number
614429 FDA UDI
Primary DI / UDI-DI
04046964900068 FDA UDI
510(k) Number
K050857 FDA UDI
K160889 FDA UDI
FDA Product Code
NVM FDA UDI
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Peripheral angioplasty balloon catheter, basic

The BIB catheter is a sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic peripheral arteries. This device features multiple lumens and can be used as an over-the-wire type or rapid exchange type with cutting/scoring elements.

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

Cleared under the same submission

K050857 also covers:

K160889 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Braun Interventional Systems, Inc

Sources (1)

  • FDA UDI 04b043b1-1c86-4fa9-b536-eed4054683b4 38 fields · synced Jul 18, 2026