DEVICE: Cardiac Insulation Pad Adult Sterile (05391530750127)

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Device Identifier (DI) Information

Cardiac Insulation Pad Adult Sterile
Adult - Sterile
FD-1001
DMC MEDICAL LIMITED
05391530750127
GS1
1
Cardiac Insulation Pad Adult Sterile
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 11, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
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Secondary DI

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

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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
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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