Catalog Number

10010

Brand Name

Sterile Sampling Line

Version/Model Number

AK-100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

6f561ca9-dab6-4814-8141-a7a954cda600

Public Version Date

March 09, 2022

Public Version Number

3

DI Record Publish Date

January 13, 2017

Package DI Number

07640125650020

Quantity per Package

60

Contains DI Package

07640125650013

Package Discontinue Date

-

Package Status

-

Package Type

-