FDA.reportPublic FDA data

BIB®

Primary DI
04046955048946
Brand
BIB®
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
614461
Catalog number
614461
Device description
BB070 BIB CATHETER 26 6 16F
Published
2016-10-28
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
K161451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161451000BIB Stent Placement CatheterNuMED, Inc.2016-09-22NVM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955048946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955048946040469550489464046955048946

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 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
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
04046964899706BIB®B BRAUN INTERVENTIONAL SYSTEMS, INCNVM2016-09-23