CueSee® Hyperbaric X-High
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…
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.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Eurotrol B.V., Netherlands |
|---|---|
| FDA product code | JJS |
| Device type | Controls For Blood-Gases, (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K955340 |
| Record published | 2021-06-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Product box of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 164.002.004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 16 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 11 |
| Architect | Abbott Laboratories | 7 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Blood Gas and Electrolyte Control | Edan Instruments, Inc. | 3 |
| VKR-7 | Radiometer America, Inc. | 1 |
| Mission Control, Level 1 | Diamond Diagnostics Inc. | 1 |
| Autocheck 3+, Level 1, S7335 | Radiometer Medical APS | 1 |
| Autocheck 3+, Level 4, S7365 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 4 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 3 | Radiometer Medical APS | 1 |
| QC Adaptor | Radiometer Medical APS | 1 |
Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152553 | 2016-04-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.