Catalog Number

10001

Brand Name

Sepax single-use kit

Version/Model Number

CS-490.1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Public Device Record Key

d1060f24-d66d-40b6-86bd-a6e79f5b21fd

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2016

Package DI Number

07640125650129

Quantity per Package

6

Contains DI Package

07640125650112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-