FDA.reportPublic FDA data

NA

Primary DI
04046963353131
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
622511
Catalog number
622511
Device description
PTCA KIT INFLATION DEVICE 25 ML
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963353131PrimaryGS10
04022495281562Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963353131040469633531314046963353131
04022495281562040224952815624022495281562

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955836383Infusomat®4906554906552024-08-15
04046955836406Infusomat®4906564906562024-08-15
04046955664214B.BRAUN8713142U-998713142U-992026-07-12
04046964182631Infusomat®3620433620432016-09-23
04046964182679Infusomat®3624323624322016-09-23
04046964185922Infusomat®4900374900372016-09-23
04046964186080Infusomat®4901004901002016-09-23
04046964186103Infusomat®4901014901012016-09-23
04046964186141Infusomat®4901044901042016-09-23
04046964186165Infusomat®4901054901052016-09-23
04046964294013Infusomat®3624313624312016-09-23
04046964294570Infusomat®3634193634192016-09-23
04046964294617Infusomat®3634213634212016-09-23
04046964294679Infusomat®3634303634302016-09-23
04046964186127Infusomat®4901024901022016-09-23
04046964294556Infusomat®3634103634102016-09-23
04046955850822Omnifix®4616025V-024616025V-022026-03-08
04046963452131Omnifix™4616308F-024616308F-022016-09-23
04046964291647CONTIPLEX®3316763316762016-09-23
04046964291807CONTIPLEX®3321293321292016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
06938327909215Sinton Medical ProductsShenzhen Boon Medical Supply Co., Ltd.DXT2026-03-27
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
10193489065824NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066029NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066043NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066081NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065916NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066067NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066104NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066142NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066159NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065848NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065855NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065886NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065893NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065923NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065930NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065947NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065954NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065961NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065978NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065985NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05