Catalog Number

-

Brand Name

AXP Disposable Processing Bagset

Version/Model Number

8-5101

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

Yes

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

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

62d507a8-f0ab-4595-a2c2-2ccfa4eb48d7

Public Version Date

January 12, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

10886368000305

Quantity per Package

24

Contains DI Package

00886368000308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case