Duns Number:412925992
Device Description: CueSee® CO-OX S3B is an unassayed material for professional use containing total hemoglobi CueSee® CO-OX S3B is an unassayed material for professional use containing total hemoglobin (tHb) with fractions of oxygenated hemoglobin (FO2Hb), fractions of carboxyhemoglobin (FCOHb) and fractions 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
AN01718A02
Brand Name
CueSee® CO-OX
Version/Model Number
S3B
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
c80e0cd0-1c66-4b3e-9e76-c718a169888e
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 19, 2021
Package DI Number
08718734961611
Quantity per Package
5
Contains DI Package
08718734961574
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 |