AccessGUDID - DEVICE: Kryo (B199GDMR75600)

GUDID

Device Identifier (DI) Information

Brand Name: Kryo
Version or Model: MR7-560
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GDMR7-560
Company Name: PLANER LIMITED

Primary DI Number: B199GDMR75600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 217190495 *Terms of Use

Device Description: MR7 Controller for use with legacy Kryo560 freezers wishing to upgrade from MRV to MR7

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?
35829	Freezer control unit, programmable	A mains electricity (AC-powered) unit used together with a specific freezer where it is important that a certain predetermined freezing pattern is followed in order to preserve the contents of the freezer. This pattern may differ according to various considerations, e.g., lowering of temperature by steps over a given time. A pre-set program will be imposed upon the freezer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSP	Apparatus, Cell-Freezing And Reagents

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: 2ce04953-af38-4dda-98ac-8623cde905a4
Public Version Date: May 08, 2023
Public Version Number: 1
DI Record Publish Date: April 30, 2023