Catalog Number

000GH100

Brand Name

GEM Hemochron 100 System

Version/Model Number

000GH100

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

K202101

Product Code

JPA

Product Code Name

System, Multipurpose For In Vitro Coagulation Studies

Public Device Record Key

aba4893c-6738-4938-9487-677e4e518c69

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

-