AccessGUDID - DEVICE: Autonomous Portable Refrigeration Unit (00860006680909)

GUDID

Device Identifier (DI) Information

Brand Name: Autonomous Portable Refrigeration Unit
Version or Model: 6L-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Delta Development Team, Inc

Primary DI Number: 00860006680909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081279605 *Terms of Use
Previous DI: 00195893765478

Device Description: Portable blood refrigerator, battery powered, 6 liter

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?
35486	Blood refrigerator	An electrically-powered device intended to be used to store and/or transport whole blood and blood components (e.g., blood cells, plasma) while keeping them cold (temperatures from 1° to 6° Celsius). It may include handles and/or wheels for transportation, internal shelving for storage and easy location of blood containers (e.g., bags); a corrosion-resistant (typically stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; and sensors, controls, monitors, chart recorders (week-long recordings are typical), and alarms (over temperature, under temperature, and power failure).	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: b28d75f1-b037-4884-83be-189c7fa7c1c7
Public Version Date: June 08, 2021
Public Version Number: 1
DI Record Publish Date: May 31, 2021