Z-MED II X™ 618731

GUDID 04046964315800

Z-MED II-X 16X6X9X7X100X.035 PDZ731

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter

• Primary Device ID: 04046964315800
• NIH Device Record Key: 65aa72e2-0a98-4b7d-a9be-3986dc499128
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-MED II X™
• Version Model Number: 618731
• Catalog Number: 618731
• Company DUNS: 784259751
• Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com
• Phone: +1(877)836-2228
• Email: GUDID.BBMUS_Service@bbraun.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temp
• Special Storage Condition, Specify: Between 0 and 0
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04046964315800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022722

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-24
• Device Publish Date: 2016-08-09

On-Brand Devices [Z-MED II X™]

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