DEVICE: Z-MED™ (04046964328640)

Device Identifier (DI) Information

Z-MED™
610451
Not in Commercial Distribution
610451
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964328640
GS1
August 04, 2021
1
784259751 *Terms of Use
PDZ301 SPECIAL Z-MED 5X2X85
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
17453 Cardiac valvuloplasty catheter
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LIT Catheter, angioplasty, peripheral, transluminal
OZT Balloon aortic valvuloplasty
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K122012 000
K991977 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: ROOM TEMP AWAY FROM SUNLIGHT
Special Storage Condition, Specify:
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ada9ad1d-32e9-4881-91ec-ed3241552264
November 02, 2022
5
August 09, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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