Z-MED™

Primary DI
04046964335914
Brand
Z-MED™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
611672
Catalog number
611672
Device description
SO076 Z-MED 35X6X100
Published
2016-08-09
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
LITCatheter, angioplasty, peripheral, transluminal
OZTBalloon aortic valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2
OZTBalloon Aortic ValvuloplastyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964335914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964335914040469643359144046964335914

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Store at room temp

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
No natural rubber latex
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
08033477048772REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048802REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048833REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048864REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048888REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048925REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048956REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048987REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049014REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049045REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049069REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049076REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049106REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049137REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049168REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049199REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049212REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049229REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049250REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049281REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049311REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049373REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049434REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049397REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477049090REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048727REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048734REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048765REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048796REEF HPMEDTRONIC, INC.LIT2016-06-19
08033477048819REEF HPMEDTRONIC, INC.LIT2016-06-19