Blood Gas and Electrolyte Control
3 catalogue numbers from Level 3, listed by Edan Instruments, Inc., China, under Controls For Blood-Gases, (Assayed And Unassayed). 1 manufacturer in China is registered for this product code.
1manufacturer
3catalogue numbers in this listing
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 | Edan Instruments, Inc., China |
|---|---|
| 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) | K151978 |
| Record published | 2016-09-01 |
| Record revised | 2018-07-06 (version 3) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Level 3 | 5 | In distribution | |
| Level 2 | 5 | In distribution | |
| Level 1 | 5 | 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 |
| 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 |
| Qualicheck 4+, Level 2 | Radiometer Medical APS | 1 |
Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)
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.