AXP Docking Station - Cord blood processing system docking station - Thermogenesis Corp.

Duns Number:080690327

Device Description: Cord blood processing system docking station

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More Product Details

Catalog Number

8-5103

Brand Name

AXP Docking Station

Version/Model Number

8-5103

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

BK070006,BK070006

Product Code Details

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Device Record Status

Public Device Record Key

843325ae-33d4-4104-806d-13f3c6acf17f

Public Version Date

January 12, 2021

Public Version Number

5

DI Record Publish Date

April 05, 2017

Additional Identifiers

Package DI Number

10886368000367

Quantity per Package

1

Contains DI Package

00886368000360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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