Catalog Number

-

Brand Name

Actalyke XL, (CSA/CE), W/ Flash Memory

Version/Model Number

5770004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K020914

Product Code

JBP

Product Code Name

ACTIVATED WHOLE BLOOD CLOTTING TIME

Public Device Record Key

1da00586-f32c-421a-a4e1-069904db4067

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-