AccessGUDID - DEVICE: Electric single chiller (00810072351210)

GUDID

Device Identifier (DI) Information

Brand Name: Electric single chiller
Version or Model: Electric single chiller
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 700.000
Company Name: Cole Instruments Inc

Primary DI Number: 00810072351210
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078573265 *Terms of Use

Device Description: Device is used to chill follicles in between the extraction from the donor area and insertion in the recipient area for hair transplantation.

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):	No
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?
60262	Cooling laboratory mixer	A mains electricity (AC-powered) electromechanical device intended to be used in the clinical laboratory to mix two or more materials under regulated cool/cold temperatures (e.g., between 2? and 20? Celsius). It typically includes mixing and cooling modules; a microcontroller for process automation, temperature monitoring, and with timer/alarm; solution vial holder; and sometimes an injection pump. The device is often used for the cryopreparation of cord blood units for stem cell cryopreservation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0799f211-6214-4711-b97d-ce357e9e43e3
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022