Duns Number:412925992
Device Description: CueSee® Hyperbaric is an assayed, quality control material for professional use in the ver CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers.
Catalog Number
164.002.004
Brand Name
CueSee® Hyperbaric X-High
Version/Model Number
164.002.004
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
K955340,K955340
Product Code
JJS
Product Code Name
Controls For Blood-Gases, (Assayed And Unassayed)
Public Device Record Key
78e02d51-1e96-493b-a79d-d7a117cb66c2
Public Version Date
June 16, 2021
Public Version Number
1
DI Record Publish Date
June 08, 2021
Package DI Number
08718734961109
Quantity per Package
4
Contains DI Package
08718734961093
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 |