Catalog Number

BC-FA-00201

Brand Name

HemoScreen

Version/Model Number

CBC Sampler

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

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

K180020,K180020,K180020,K180020

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

95c45829-a81b-4810-909b-9e41479e0f82

Public Version Date

September 30, 2022

Public Version Number

6

DI Record Publish Date

January 14, 2019

Package DI Number

17290016991038

Quantity per Package

10

Contains DI Package

07290016991048

Package Discontinue Date

September 30, 2022

Package Status

Not in Commercial Distribution

Package Type

Carton box