Duns Number:195501127
Device Description: HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a r HemataStat II Microhematocrit System is a small, lightweight centrifuge which provides a rapid and accurate mircohematocrit determination using capillary or venous blood samples.
Catalog Number
100-133
Brand Name
HemataSTAT II Centrifuge
Version/Model Number
100-133
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
-
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
GKG
Product Code Name
Centrifuge, Hematocrit
Public Device Record Key
7527add8-b07a-49de-9520-6296c2dc874e
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |