Z-MED II X™ 618733

GUDID 04046964315848

Z-MED II-X 18X4X10X8X100X.035 PDZ733


Cardiac valvuloplasty catheter
Primary Device ID04046964315848
NIH Device Record Key944f8b64-0487-4f8b-881d-a6f624a6e709
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-MED II X™
Version Model Number618733
Catalog Number618733
Company DUNS784259751
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

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
GS104046964315848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code



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 II X™]

04046964316258Z-MEDII-X 30X4X16X11X100X.035 PDZ753
04046964316234Z-MEDII-X 28X4X16X11X100X.035 PDZ752
04046964316210Z-MED II-X 25X6X14X9X100X.035 PDZ751
04046964316197Z-MED II-X 25X5X14X9X100X.035 PDZ750
04046964316173Z-MED II-X 25X4X14X9X100X.035 PDZ749
04046964316159Z-MED II-X 25X3X14X9X100X.035 PDZ748
04046964316135Z-MED II-X 23X6X13X9X100X.035 PDZ747
04046964316111Z-MED II-X 23X5X13X9X100X.035 PDZ746
04046964316098Z-MED II-X 23X4X13X9X100X.035 PDZ745
04046964316074Z-MED II-X 23X3X13X9X100X.035 PDZ744
04046964316043Z-MED II-X 22X6X12X9X100X.035 PDZ743
04046964316036Z-MED II-X 22X5X12X9X100X.035 PDZ742
04046964316005Z-MED II-X 22X4X12X9X100X.035 PDZ741
04046964315985Z-MED II-X 22X3X12X9X100X.035 PDZ740
04046964315961Z-MED II-X 20X6X12X8X100X.035 PDZ739
04046964315947Z-MED II-X 20X5X12X8X100X.035 PDZ738
04046964315923Z-MED II-X 20X4X12X8X100X.035 PDZ737
04046964315909Z-MED II-X 20X3X12X8X100X.035 PDZ736
04046964315893Z-MED II-X 18X6X10X8X100X.035 PDZ735
04046964315862Z-MED II-X 18X5X10X8X100X.035 PDZ734
04046964315848Z-MED II-X 18X4X10X8X100X.035 PDZ733
04046964315824Z-MED II-X 18X3X10X8X100X.035 PDZ732
04046964315800Z-MED II-X 16X6X9X7X100X.035 PDZ731
04046964315787Z-MED II-X 16X5X9X7X100X.035 PDZ730
04046964315763Z-MED II-X 16X4X9X7X100X.035 PDZ729
04046964315749Z-MED II-X 16X3X9X7X100X.035 PDZ728
04046964315718Z-MED II-X 15X6X9X7X100X.035 PDZ727
04046964315695Z-MED II-X 15X5X9X7X100X.035 PDZ726
04046964315657Z-MED II-X 15X3X9X7X100X.035 PDZ724
04046964315633Z-MED II-X 14X6X9X7X100X.035 PDZ723
04046964315619Z-MED II-X 14X5X9X7X100X.035 PDZ722
04046964315596Z-MED II-X 14X4X9X7X100X.035 PDZ721
04046964315572Z-MED II-X 14X3X9X7X100X.035 PDZ720
04046964315558Z-MED II-X 12X6X8X6X100X.035 PDZ719
04046964315527Z-MED II-X 12X5X8X6X100X.035 PDZ718
04046964315510Z-MED II-X 12X4X8X6X100X.035 PDZ717
04046964315497Z-MED II-X 12X3X8X6X100X.035 PDZ716
04046964315473Z-MED II-X 12X2X8X6X100X.035 PDZ715
04046964315442Z-MED II-X 10X6X7X6X100X.035 PDZ714
04046964315428Z-MED II-X 10X5X7X6X100X.035 PDZ713
04046964315404Z-MED II-X 10X4X7X6X100X.035 PDZ712
04046964315398Z-MED II-X 10X3X7X6X100X.035 PDZ711
04046964315367Z-MED II-X 10X2X7X6X100X.035 PDZ710
04046964315350Z-MED II-X 9X6X7X6X100X.035 PDZ709
04046964315336Z-MED II-X 9X5X7X6X100X.035 PDZ708
04046964315312Z-MED II-X 9X4X7X6X100X.035 PDZ707
04046964315299Z-MED II-X 9X3X7X6X100X.035 PDZ706
04046964315275Z-MED II-X 9X2X7X6X100X.035 PDZ705
04046964315251Z-MED II-X 8X6X7X6X100X.035 PDZ704
04046964315237Z-MED II-X 8X5X7X6X100X.035 PDZ703

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