HERAfreeze Ultra Low Temperature Freezer - HERAfreeze HDE Series -40C Ultra-Low Temperature - KEY SCIENTIFIC INC

Duns Number:938286804

Device Description: HERAfreeze HDE Series -40C Ultra-Low Temperature Freezers

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More Product Details

Catalog Number


Brand Name

HERAfreeze Ultra Low Temperature Freezer

Version/Model Number


Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date


Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)


Device labeled as "Not made with natural rubber latex"


For Single-Use


Prescription Use (Rx)


Over the Counter (OTC)




Combination Product


Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)


FDA Premarket Submission


Product Code Details

Product Code


Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key


Public Version Date

November 13, 2019

Public Version Number


DI Record Publish Date

November 05, 2019

Additional Identifiers

Package DI Number


Quantity per Package


Contains DI Package


Package Discontinue Date


Package Status


Package Type


"KEY SCIENTIFIC INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 255