AccessGUDID - DEVICE: Thermo Scientific Revco Freezer (10816934021175)

GUDID

Device Identifier (DI) Information

Brand Name: Thermo Scientific Revco Freezer
Version or Model: RDE40040LA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RDE40040LA
Company Name: KEY SCIENTIFIC INC

Primary DI Number: 10816934021175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 938286804 *Terms of Use

Device Description: Thermo Scientific Revco RDE Series -40C Ultra-Low Temperature Freezer

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?
40513	Ultralow-temperature laboratory freezer	A mains electricity (AC-powered) freezer designed for the storage of laboratory products and sample materials, e.g., in vitro diagnostic (IVD) reagents and laboratory tissue/body fluid samples that require extremely low temperatures, usually in the range from -40 to -90? Celsius. It will typically have a corrosion resistant (typically stainless steel) interior minimizing the risk of adulteration, contamination, and/or corrosion of the contents and a shelving configuration appropriate for storage/easy localization of the products. It will typically be programmable, have defrost capabilities, a built-in alarm system to warn against temperature variations, and a recorder to record events.	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: 34a31738-4bdb-4239-8292-b2c780095009
Public Version Date: November 13, 2019
Public Version Number: 1
DI Record Publish Date: November 05, 2019