DEVICE: BIB® (04046955049004)

Device Identifier (DI) Information

BIB®
614467
In Commercial Distribution
614467
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046955049004
GS1

1
784259751 *Terms of Use
BB076 BIB CATHETER 30 6 16F
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17184 Peripheral angioplasty balloon catheter, basic
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NVM Catheter, angioplasty, peripheral, transluminal, dual-balloon
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K161451 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify:
Storage Environment Temperature: between 5 and 45 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Diameter (mm) : 30.000 MM
Device Size Text, specify: Length : 6.000 CM
Device Size Text, specify: Length of catheter : 110.000 CM
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Device Record Status

382cb447-350e-45ce-a29b-4c5281557c22
September 07, 2023
7
October 28, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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