DEVICE: BIB® (04046964899720)
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Device Identifier (DI) Information
BIB®
614392
In Commercial Distribution
614392
B BRAUN INTERVENTIONAL SYSTEMS, INC
614392
In Commercial Distribution
614392
B BRAUN INTERVENTIONAL SYSTEMS, INC
BB044 BIB Catheter 8 4.5 8F
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. 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NVM | Catheter, angioplasty, peripheral, transluminal, dual-balloon |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K050857 | 000 |
| K160889 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 5 and 45 Degrees Celsius |
| Special Storage Condition, Specify: Keep away from sunlight |
| Special Storage Condition, Specify: |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Length : 45.000 MM |
| Device Size Text, specify: Length of catheter : 110.000 CM |
| Device Size Text, specify: Diameter (mm) : 8.000 MM |
Device Record Status
5cde46c9-1c52-483b-8ba0-03252c1c1933
September 07, 2023
7
September 23, 2016
September 07, 2023
7
September 23, 2016
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com