Catalog Number

-

Brand Name

CellTrans

Version/Model Number

ABT4510

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"

Yes

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

K022489,K022489

Product Code

CAC

Product Code Name

Apparatus, Autotransfusion

Public Device Record Key

69b70de9-63ea-4afe-95ba-7390134d68db

Public Version Date

January 21, 2019

Public Version Number

1

DI Record Publish Date

December 21, 2018

Package DI Number

25060238201135

Quantity per Package

15

Contains DI Package

15060238201138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box