Catalog Number

-

Brand Name

hema-screen SPECIFIC

Version/Model Number

HSSP-25

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

273de6a4-41f8-432d-bf79-b5d23c918027

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20722355001078

Quantity per Package

10

Contains DI Package

10722355001071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 10