BIB® 614627

GUDID 04046955719259

BB084 BIB CATHETER 16MMX6CMX9FR

B BRAUN INTERVENTIONAL SYSTEMS, INC

Peripheral angioplasty balloon catheter, basic
Primary Device ID04046955719259
NIH Device Record Key59d87d4d-3c5f-430a-bbe3-00094edee036
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIB®
Version Model Number614627
Catalog Number614627
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com
Phone+1(877)836-2228
EmailGUDID.BBMUS_Service@bbraun.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0
Special Storage Condition, SpecifyBetween 0 and 0 *KEEP OUT OF DIRECT SUNLIGHT
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0
Storage Environment TemperatureBetween 5 Degrees Celsius and 45 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0

Device Identifiers

Device Issuing AgencyDevice ID
GS104046955719259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVMCatheter, angioplasty, peripheral, transluminal, dual-balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-21

On-Brand Devices [BIB®]

04046964901355BB058 BIB Catheter 15 4.5 9F
04046964900334BB050 BIB Catheter 10 5.5 8F
04046964900327BB049 BIB Catheter 10 5 8F
04046964900310BB021 BIB Catheter 24 5.5 11F
04046964900303BB036 BIB Catheter 24 5 11F
04046964900297BB018 BIB Catheter 24 4.5 11F
04046964900280BB015 BIB Catheter 24 4 11F
04046964900273BB067 BIB Catheter 24 3.5 11F
04046964900266BB012 BIB Catheter 24 3 11F
04046964900259BB066 BIB Catheter 22 5.5 11F
04046964900242BB065 BIB Catheter 22 5 11F
04046964900235BB064 BIB Catheter 22 4.5 11F
04046964900228BB063 BIB Catheter 22 4 11F
04046964900211BB062 BIB Catheter 22 3.5 11F
04046964900204BB061 BIB Catheter 22 3 11F
04046964900198BB020 BIB Catheter 20 5.5 10F
04046964900181BB032 BIB Catheter 20 5 10F
04046964900174BB017 BIB Catheter 20 4.5 10F
04046964900167BB014 BIB Catheter 20 4 10F
04046964900150BB042 BIB Catheter 20 3.5 10F
04046964900143BB011 BIB Catheter 20 3 10F
04046964900136BB031 BIB Catheter 18 5.5 10F
04046964900129BB030 BIB Catheter 18 5 10F
04046964900112BB029 BIB Catheter 18 4.5 10F
04046964900105BB041 BIB Catheter 18 4 10F
04046964900099BB027 BIB Catheter 18 3.5 10F
04046964900082BB040 BIB Catheter 18 3 10F
04046964900075BB024 BIB Catheter 18 2.5 10F
04046964900068BB019 BIB Catheter 16 5.5 9F
04046964900051BB028 BIB Catheter 16 5 9F
04046964900044BB016 BIB Catheter 16 4.5 9F
04046964900037BB013 BIB Catheter 16 4 9F
04046964900020BB026 BIB Catheter 16 3.5 9F
04046964900013BB010 BIB Catheter 16 3 9F
04046964900006BB023 BIB Catheter 16 2.5 9F
04046964899997BB060 BIB Catheter 15 5.5 9F
04046964899980BB059 BIB Catheter 15 5 9F
04046964899973BB057 BIB Catheter 15 4 9F
04046964899966BB056 BIB Catheter 15 3.5 9F
04046964899959BB055 BIB Catheter 15 3 9F
04046964899942BB054 BIB Catheter 15 2.5 9F
04046964899935BB053 BIB Catheter 14 5.5 8F
04046964899928BB039 BIB Catheter 14 5 8F
04046964899911BB035 BIB Catheter 14 4.5 8F
04046964899904BB038 BIB Catheter 14 4 8F
04046964899898BB025 BIB Catheter 14 3.5 8F
04046964899881BB052 BIB Catheter 14 3 8F
04046964899874BB022 BIB Catheter 14 2.5 8F
04046964899867BB051 BIB Catheter 12 5.5 8F
04046964899850BB034 BIB Catheter 12 5 8F

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