Duns Number:412925992
Device Description: CueSee® CO-OX S5A is an assayed quality control material for professional use to verify th CueSee® CO-OX S5A is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).
Catalog Number
AN01486A03
Brand Name
CueSee® CO-OX
Version/Model Number
S5A
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
GGM
Product Code Name
Control, Hemoglobin
Public Device Record Key
6c4dd05a-aae5-4f58-9ad6-dba1b052f257
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 19, 2021
Package DI Number
08718734961079
Quantity per Package
5
Contains DI Package
08718734961048
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |