Catalog Number

ELITE

Brand Name

Hemochron Whole Blood Microcoagulation System

Version/Model Number

ELITE

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

-

Product Code

JPA

Product Code Name

System, Multipurpose For In Vitro Coagulation Studies

Public Device Record Key

5df49d88-5450-4950-bdfc-992ded074653

Public Version Date

August 31, 2022

Public Version Number

7

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-