Z-MED X™ 618419

GUDID 04046964314421

Z-MED-X 12X6X7X6X100X.035 PDZ419

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter

• Primary Device ID: 04046964314421
• NIH Device Record Key: c502d31d-e7aa-437e-9751-261be1ab4d5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Z-MED X™
• Version Model Number: 618419
• Catalog Number: 618419
• 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

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 *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
• 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	04046964314421 [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: 2020-04-07
• Device Publish Date: 2016-08-09

On-Brand Devices [Z-MED X™]

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