DEVICE: Cook (00827002182264)

Device Identifier (DI) Information

Cook
G18226
In Commercial Distribution
K-FTH-1012
WILLIAM A. COOK AUSTRALIA PTY. LTD.
00827002182264
GS1

1
758568000 *Terms of Use
Test Tube Heater
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46944 Test tube heater
An electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQG ACCESSORY, ASSISTED REPRODUCTION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K983609 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in dark, dry, cool place
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Clinically Relevant Size

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

85302ff4-605a-4726-824f-be6cf7d5607d
July 06, 2018
3
September 24, 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
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(812)330-5494
sharedservices@cookmedical.com
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