Catalog Number

8-5100

Brand Name

AXP Start Up Accessory Kit

Version/Model Number

8-5100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

d474ed03-07b8-4da0-a209-da57eca31ebc

Public Version Date

January 12, 2021

Public Version Number

5

DI Record Publish Date

April 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-