Catalog Number

HE-ESV

Brand Name

Hemochron Whole Blood Coagulation System

Version/Model Number

HE-ESV

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K990449

Product Code

JPA

Product Code Name

System, Multipurpose For In Vitro Coagulation Studies

Public Device Record Key

88f554d2-b131-4c2c-bb49-d8507c199ecc

Public Version Date

August 31, 2022

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-