Catalog Number

7900005

Brand Name

CellSave

Version/Model Number

7900005

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

JKA

Product Code Name

Tubes, vials, systems, serum separators, blood collection

Public Device Record Key

c42a8f2d-87f9-4d63-94dc-70387e995cb4

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

20888385000044

Quantity per Package

1000

Contains DI Package

10888385000047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case