DEVICE: Z-MED II™ (04046964335976)
Device Identifier (DI) Information
Z-MED II™
611675
In Commercial Distribution
611675
B BRAUN INTERVENTIONAL SYSTEMS, INC
611675
In Commercial Distribution
611675
B BRAUN INTERVENTIONAL SYSTEMS, INC
SO079 SPECIAL ZMED II 30X5X100
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LIT | Catheter, angioplasty, peripheral, transluminal |
DQY | CATHETER, PERCUTANEOUS |
OZT | Balloon aortic valvuloplasty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: ROOM TEMP AWAY FROM SUNLIGHT |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e53d55c5-1adf-4db3-99e5-262288c96087
March 29, 2018
2
August 09, 2016
March 29, 2018
2
August 09, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)836-2228
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com