Duns Number:330046442
Device Description: For the quantitative determination of hemoglobin in whole blood.
Catalog Number
3000-3012-0765
Brand Name
Hemo Control Hemoglobin Microcuvette
Version/Model Number
3000-3012-0765
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
GKR
Product Code Name
System, Hemoglobin, Automated
Public Device Record Key
e295f6ab-3838-430a-a71b-1a84346d217c
Public Version Date
May 18, 2021
Public Version Number
1
DI Record Publish Date
May 10, 2021
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. | 8 |