AccessGUDID - DEVICE: Cook (00827002182264)

GUDID

Device Identifier (DI) Information

Brand Name: Cook
Version or Model: G18226
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K-FTH-1012
Company Name: WILLIAM A. COOK AUSTRALIA PTY. LTD.

Primary DI Number: 00827002182264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 758568000 *Terms of Use

Device Description: Test Tube Heater

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 85302ff4-605a-4726-824f-be6cf7d5607d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: 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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(812)330-5494
Email: sharedservices@cookmedical.com

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