Catalog Number

000GACT-LR

Brand Name

GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR)

Version/Model Number

000GACT-LR

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

K202101,K202101

Product Code

JBP

Product Code Name

Activated Whole Blood Clotting Time

Public Device Record Key

cd91511d-9b8f-4d9e-9cf8-99c24be6365e

Public Version Date

August 31, 2022

Public Version Number

2

DI Record Publish Date

January 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-