DEVICE: COEfficient™ (04046964334726)
Device Identifier (DI) Information
COEfficient™
611246
In Commercial Distribution
611246
B BRAUN INTERVENTIONAL SYSTEMS, INC
611246
In Commercial Distribution
611246
B BRAUN INTERVENTIONAL SYSTEMS, INC
COE151 COEFFICIENT BALLOON 11 X 3 X 135
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 |
---|---|
MAD | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K014124 | 000 |
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
b466deda-70ab-47af-9096-9c8fbc413672
July 06, 2018
3
August 09, 2016
July 06, 2018
3
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