DEVICE: Cardiac Insulation Pad Adult Sterile (05391530750127)
Device Identifier (DI) Information
Cardiac Insulation Pad Adult Sterile
Adult - Sterile
In Commercial Distribution
FD-1001
DMC MEDICAL LIMITED
Adult - Sterile
In Commercial Distribution
FD-1001
DMC MEDICAL LIMITED
Cardiac Insulation Pad Adult Sterile
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35973 | Cardiac insulation pad |
A thin and pliable cushion designed to be placed around the heart in conjunction with cold cardioplegia during cardiac surgery with extracorporeal circulation. The device is intended to help to prevent rapid rewarming of the heart. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K992932 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a66474fd-fe23-4b3f-ae49-1d2e119f0c03
July 06, 2018
3
August 11, 2016
July 06, 2018
3
August 11, 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 |
---|---|---|---|---|---|
05391530750141 | 8 | 05391530750134 | In Commercial Distribution | ||
05391530750134 | 10 | 05391530750127 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined