Thermogenesis BioArchive - BioArchive Device 220V - Thermogenesis Corp.

Duns Number:080690327

Device Description: BioArchive Device 220V

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More Product Details

Catalog Number

-

Brand Name

Thermogenesis BioArchive

Version/Model Number

8-4000-1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Device Record Status

Public Device Record Key

4f535d42-d0a2-4f63-b8f8-04aeea8b4b47

Public Version Date

October 11, 2021

Public Version Number

1

DI Record Publish Date

October 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERMOGENESIS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 26