Duns Number:330046442
Device Description: For the quantitative determination of hemoglobin in whole blood.
Catalog Number
900-500
Brand Name
DiaSpect Tm Cuvettes
Version/Model Number
7049-3013-0369
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
BK200520,BK200520,BK200520
Product Code
GKR
Product Code Name
System, Hemoglobin, Automated
Public Device Record Key
42cfebd8-8687-45c9-bba6-8a8cfe5f7c66
Public Version Date
March 19, 2021
Public Version Number
1
DI Record Publish Date
March 11, 2021
Package DI Number
24048534001964
Quantity per Package
10
Contains DI Package
14048534001967
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardboard box
| 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 |