FDA.reportPublic FDA data

Z-MED™

Primary DI
04046964328626
Brand
Z-MED™
Company
B BRAUN INTERVENTIONAL SYSTEMS, INC
Model
610450
Catalog number
610450
Device description
PDZ300 SPECIAL Z-MED 4X2X85
Published
2016-08-09
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
KNQDilator, esophageal
LITCatheter, angioplasty, peripheral, transluminal
OZTBalloon aortic valvuloplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2
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
04046964328626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964328626040469643286264046964328626

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, Specify00ROOM TEMP AWAY FROM SUNLIGHT

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
06936937786646STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792364STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792371STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792388STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792395STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792401STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792418STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792425STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
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
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15