Duns Number:045361136
Device Description: For the quantitative determination of hemoglobin in capillary, venous or arterial whole bl For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
Catalog Number
3016-050
Brand Name
HemoPoint® H2 n•x•t Microcuvettes
Version/Model Number
3016-050
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
45835534-4852-40e6-a8c9-156b3c04d3d5
Public Version Date
August 31, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
00657498000212
Quantity per Package
4
Contains DI Package
00657498301654
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |