Catalog Number

-

Brand Name

hema-screen

Version/Model Number

HS-100

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

-

Product Code

KHE

Product Code Name

REAGENT, OCCULT BLOOD

Public Device Record Key

a61eaf7d-96f5-4857-8334-37c2eeed8162

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

50722355001017

Quantity per Package

20

Contains DI Package

40722355001010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 20