Z-MED X™ 618406

GUDID 04046964314179

Z-MED-X 9X3X7X6X100X.035 PDZ406

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964314179
NIH Device Record Key9ca3a30a-da12-4dde-a741-2f67a950d88f
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-MED X™
Version Model Number618406
Catalog Number618406
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)836-2228
Email[email protected]

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964314179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2016-08-09

On-Brand Devices [Z-MED X™]

04046964315152Z-MED-X 30X6X13X9X100X.035 PDZ455
04046964315121Z-MED-X 30X5X13X9X100X.035 PDZ454
04046964315114Z-MED-X 30X4X13X9X100X.035 PDZ453
04046964315084Z-MED-X 30X3X13X9X100X.035 PDZ452
04046964315060Z-MED-X 28X6X12X9X100X.035 PDZ451
04046964315046Z-MED-X 28X5X12X9X100X.035 PDZ450
04046964315022Z-MED-X 28X4X12X9X100X.035 PDZ449
04046964315008Z-MED-X 28X3X12X9X100X.035 PDZ448
04046964314988Z-MED-X 25X6X12X9X100X.035 PDZ447
04046964314964Z-MED-X 25X5X12X9X100X.035 PDZ446
04046964314957Z-MED-X 25X4X12X9X100X.035 PDZ445
04046964314926Z-MED-X 25X3X12X9X100X.035 PDZ444
04046964314902Z-MED-X 22X6X11X9X100X.035 PDZ443
04046964314889Z-MED-X 22X5X11X9X100X.035 PDZ442
04046964314865Z-MED-X 22X4X11X9X100X.035 PDZ441
04046964314841Z-MED-X 22X3X11X9X100X.035 PDZ440
04046964314827Z-MED-X 20X6X11X8X100X.035 PDZ439
04046964314803Z-MED-X 20X5X11X8X100X.035 PDZ438
04046964314797Z-MED-X 20X4X11X8X100X.035 PDZ437
04046964314766Z-MED-X 20X3X11X8X100X.035 PDZ436
04046964314759Z-MED-X 18X6X10X8X100X.035 PDZ435
04046964314735Z-MED-X 18X5X10X8X100X.035 PDZ434
04046964314711Z-MED-X 18X4X10X8X100X.035 PDZ433
04046964314698Z-MED-X 18X3X10X8X100X.035 PDZ432
04046964314674Z-MED-X 16X6X9X7X100X.035 PDZ431
04046964314650Z-MED-X 16X5X9X7X100X.035 PDZ430
04046964314629Z-MED-X 16X4X9X7X100X.035 PDZ429
04046964314605Z-MED-X 16X3X9X7X100X.035 PDZ428
04046964314582Z-MED-X 15X6X8X7X100X.035 PDZ427
04046964314568Z-MED-X 15X5X8X7X100X.035 PDZ426
04046964314544Z-MED-X 15X4X8X7X100X.035 PDZ425
04046964314520Z-MED-X 15X3X8X7X100X.035 PDZ424
04046964314506Z-MED-X 14X6X8X7X100X.035 PDZ423
04046964314483Z-MED-X 14X5X8X7X100X.035 PDZ422
04046964314469Z-MED-X 14X4X8X7X100X.035 PDZ421
04046964314445Z-MED-X 14X3X8X7X100X.035 PDZ420
04046964314421Z-MED-X 12X6X7X6X100X.035 PDZ419
04046964314407Z-MED-X 12X5X7X6X100X.035 PDZ418
04046964314384Z-MED-X 12X4X7X6X100X.035 PDZ417
04046964314360Z-MED-X 12X3X7X6X100X.035 PDZ416
04046964314353Z-MED-X 12X2X7X6X100X.035 PDZ415
04046964314339Z-MED-X 10X6X7X6X100X.035 PDZ414
04046964314315Z-MED-X 10X5X7X6X100X.035 PDZ413
04046964314292Z-MED-X 10X4X7X6X100X.035 PDZ412
04046964314278Z-MED-X 10X3X7X6X100X.035 PDZ411
04046964314261Z-MED-X 10X2X7X6X100X.035 PDZ410
04046964314230Z-MED-X 9X6X7X6X100X.035 PDZ409
04046964314216Z-MED-X 9X5X7X6X100X.035 PDZ408
04046964314193Z-MED-X 9X4X7X6X100X.035 PDZ407
04046964314179Z-MED-X 9X3X7X6X100X.035 PDZ406

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