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

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
04046955642489Seamless™6147026147022023-06-29
04046955668823COMPASS ™6139446139442021-12-07
04046955668847COMPASS ™6139456139452021-12-07
04046955668861COMPASS ™6139466139462021-12-07
04046955668885COMPASS ™6139476139472021-12-07
04046955668908COMPASS ™6139486139482021-12-07
04046955668922COMPASS ™6139496139492021-12-07
04046955668946COMPASS ™6139506139502021-12-07
04046955668960COMPASS ™6139516139512021-12-07
04046955668984COMPASS ™6139526139522021-12-07
04046955669004COMPASS ™6139536139532021-12-07
04046955669028COMPASS ™6139546139542021-12-07
04046955669042COMPASS ™6139556139552021-12-07
04046955669066COMPASS ™6139566139562021-12-07
04046955669080COMPASS ™6139576139572021-12-07
04046955669103COMPASS ™6139586139582021-12-07
04046955669127COMPASS ™6139596139592021-12-07
04046955669141COMPASS ™6139606139602021-12-07
04046955669165COMPASS ™6139616139612021-12-07
04046955669189COMPASS ™6139626139622021-12-07

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