FDA.reportPublic FDA data

Z-MED™

Primary DI
04046964555077
Brand
Z-MED™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
610235
Catalog number
610235
Device description
PDZ365 SPECIAL Z-MED 12X4X100
Published
2016-09-23
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
04046964555077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964555077040469645550774046964555077

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00ROOM TEMP DARK DRY PLACE
Special Storage Condition, Specify00Store at room temp
Special Storage Condition, Specify00Store in a dark place
Special Storage Condition, Specify00Store in a dry place

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
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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