DEVICE: Cook (00827002182264)
Device Identifier (DI) Information
Cook
G18226
In Commercial Distribution
K-FTH-1012
WILLIAM A. COOK AUSTRALIA PTY. LTD.
G18226
In Commercial Distribution
K-FTH-1012
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Test Tube Heater
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQG | ACCESSORY, ASSISTED REPRODUCTION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K983609 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in dark, dry, cool place |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
85302ff4-605a-4726-824f-be6cf7d5607d
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 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(812)330-5494
sharedservices@cookmedical.com
sharedservices@cookmedical.com