AccessGUDID - DEVICE: K2 Scientific, LLC (G136K225SDFBB0)

GUDID

Device Identifier (DI) Information

Brand Name: K2 Scientific, LLC
Version or Model: K225SDFBB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K225SDF-BB
Company Name: K2 Scientific, LLC

Primary DI Number: G136K225SDFBB0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080936069 *Terms of Use

Device Description: 25 Cu. Ft. High-Performance Laboratory, Solid Door, Blood Bank Freezer. Features an intelligent microprocessor controller with a digital display. Preset to the ideal temperature of -25°C with a standard temperature range of -10°C to -30°C. Environmentally friendly, natural refrigerants are fully compliant with new EPA/SNAP/UL regulations. The K225SDF-BB is Approved as a Class II Medical device and is manufactured under the highest quality standards: ISO 13485 – 2016.

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?
60607	Blood refrigerator/freezer	An electrically-powered device intended to be used to store and/or transport whole blood and/or blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius), or alternatively frozen (-18° to -30° Celsius). It includes refrigeration and freezing compartments with internal shelving, controls, sensors and alarms to signal out-of-range temperatures and power failures; its interior is typically corrosion-resistant (typically stainless steel or synthetic materials) to minimize the risk of adulteration, contamination, and/or corrosion of contents. The refrigeration unit is typically equipped with a safety thermostat to protect the products from freezing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSE	Refrigerator, Freezer, Blood Storage

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: 383271bf-4223-4dda-905b-a7d497c57fca
Public Version Date: January 25, 2022
Public Version Number: 1
DI Record Publish Date: January 17, 2022