Catalog Number

-

Brand Name

hema-screen ER

Version/Model Number

HSER-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

c90d2c67-76f1-4c8d-9387-86738b91ec1e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

20722355002501

Quantity per Package

20

Contains DI Package

10722355002504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 20