Catalog Number

00020303600

Brand Name

HemosIL Liquid Anti-Xa

Version/Model Number

0020303600

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

-

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

DEN190032

Product Code

QLU

Product Code Name

Anti-Factor Xa Activity Test System, Apixaban

Public Device Record Key

04a8b52c-235b-438e-9574-8d76ef375c1a

Public Version Date

July 13, 2021

Public Version Number

4

DI Record Publish Date

March 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-