Catalog Number

10015

Brand Name

Sepax single-use kit

Version/Model Number

CS-530.1

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

c87a1868-4a73-42f9-86a3-665805e18491

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2016

Package DI Number

07640125650143

Quantity per Package

6

Contains DI Package

07640125650136

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-