Catalog Number

BC-MA-00100

Brand Name

HemoScreen

Version/Model Number

CBC Sampler

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

K180020,K180020,K180020,K180020

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Public Device Record Key

72c53a76-ff77-4d5a-83c3-d5c989c361ab

Public Version Date

October 07, 2022

Public Version Number

2

DI Record Publish Date

July 19, 2022

Package DI Number

17290016991076

Quantity per Package

10

Contains DI Package

07290016991079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Catron or aluminum