Duns Number:412925992
Device Description: CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professio CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Catalog Number
221.001.010
Brand Name
CueSee® VeriSTAT QC
Version/Model Number
Level 1
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
K131595,K131595
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
712ed645-f816-4176-a1f5-376a71fdae2d
Public Version Date
October 16, 2020
Public Version Number
1
DI Record Publish Date
October 08, 2020
Package DI Number
08718734961505
Quantity per Package
10
Contains DI Package
08718734961475
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Product 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 |