FDA.reportPublic FDA data

BIB®

Primary DI
04046964899829
Brand
BIB®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
614404
Catalog number
614404
Device description
BB009 BIB Catheter 12 3.5 8F
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVMCatheter, angioplasty, peripheral, transluminal, dual-balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-BalloonCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050857000
K160889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050857000BIB PTA BALLOON CATHETERNuMED, Inc.2005-07-28NVM
K160889000BIB Stent Placement CatheterNuMED, Inc.2016-05-20NVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964899829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964899829040469648998294046964899829

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00KEEP OUT OF DIRECT SUNLIGHT
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)836-2228GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
784259751
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964309809Micro-Access Elite®6133406133402016-08-09
04046964309823Micro-Access Elite®6133416133412016-08-09
04046964309847Micro-Access Elite®6133426133422016-08-09
04046964309861Micro-Access Elite®6133436133432016-08-09
04046964309885Micro-Access Elite®6133446133442016-08-09
04046964309908Micro-Access Elite®6133456133452016-08-09
04046964309922Micro-Access Elite®6133466133462016-08-09
04046964309946Micro-Access Elite®6133476133472016-08-09
04046964309960Micro-Access Elite®6133486133482016-08-09
04046964309977Micro-Access Elite®6133496133492016-08-09
04046964310003Micro-Access Elite®6133506133502016-08-09
04046964310027Micro-Access Elite®6133516133512016-08-09
04046964310041Micro-Access Elite®6133526133522016-08-09
04046964310065Micro-Access Elite®6133536133532016-08-09
04046964310089Micro-Access Elite®6133546133542016-08-09
04046964310102Micro-Access Elite®6133556133552016-08-09
04046964310126Micro-Access Elite®6133566133562016-08-09
04046964310140Micro-Access Elite®6133576133572016-08-09
04046964310164Micro-Access Elite®6133586133582016-08-09
04046964310188Micro-Access Elite®6133596133592016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955718580BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718597BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718603BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718610BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718627BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718634BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718641BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718658BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718665BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718672BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718689BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718696BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718702BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718719BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718726BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718733BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955718740BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955719259BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2021-08-21
04046955048922BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048939BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048946BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048953BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048960BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048977BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048984BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955048991BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955049004BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046955050062BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-10-28
04046964899683BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-09-23
04046964899690BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-09-23