Duns Number:532623092
Device Description: A self-contained disposable unit in which a single blood sample is prepared and made ready A self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis
Catalog Number
BC-FA-00103
Brand Name
HemoScreen
Version/Model Number
CBC Cartridge
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,K180020
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
e8b7fa4f-040d-4d7c-b822-7929bd514eef
Public Version Date
January 28, 2022
Public Version Number
4
DI Record Publish Date
January 14, 2019
Package DI Number
07290016991024
Quantity per Package
10
Contains DI Package
07290016991017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |