DEVICE: BIB® (04046964900211)
Device Identifier (DI) Information
BIB®
614444
In Commercial Distribution
614444
B BRAUN INTERVENTIONAL SYSTEMS, INC
614444
In Commercial Distribution
614444
B BRAUN INTERVENTIONAL SYSTEMS, INC
BB062 BIB Catheter 22 3.5 11F
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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 microsurgical blades (atherotomes) to score the plaque. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NVM | Catheter, angioplasty, peripheral, transluminal, dual-balloon |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: KEEP OUT OF DIRECT SUNLIGHT |
Storage Environment Temperature: between 5 and 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Length : 35.000 MM |
Device Size Text, specify: Diameter (mm) : 22.000 MM |
Device Size Text, specify: Length of catheter : 110.000 CM |
Device Record Status
8a04ff51-0115-494c-8f90-3dfe47d92cbe
March 29, 2018
2
September 23, 2016
March 29, 2018
2
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