FDA.reportPublic FDA data

Z-MED™

Primary DI
04046964336027
Brand
Z-MED™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
611677
Catalog number
611677
Device description
SO081 SPECIAL Z-MED 22X8X100
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122012000
K991977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122012000Z-MED Z-MED IINuMED, Inc.2012-10-04OZT
K991977000TYSHAK, MODEL 102 AND Z-MED, MODEL 302NuMED, Inc.2000-09-27LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964336027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964336027040469643360274046964336027

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
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
G825CVPSI19251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI20251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI21251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI22251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI23251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI24251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI25251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI26251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI27251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI28251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
G825CVPSI29251KardiaPSIIntervention Tech, Inc. dba CorventionOZT2026-06-24
10193489069334NAMICMEDLINE INDUSTRIES, INC.LIT2021-10-28
10193489069341NAMICMEDLINE INDUSTRIES, INC.LIT2021-07-26
20193489087793MedlineMEDLINE INDUSTRIES, INC.LIT2021-05-12
H965800450750NAMICANGIODYNAMICS, INC.LIT2020-11-03
00643169843059Stretch™ Insertion ToolMEDTRONIC, INC.LIT2018-07-06
H965914003000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
H965914004000NAMICNAVILYST MEDICAL, INC.LIT2016-09-21
00643169002913Stretch™ Insertion ToolMEDTRONIC, INC.LIT2016-07-02
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