Stat Profile
STAT PROFILE pHOx PLUS/L/C/M W/R Pump Tubing Assembly
1manufacturer
9catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | JFP |
| Device type | Electrode, Ion Specific, Calcium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1145 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K061830 |
| Record published | 2016-09-16 |
| 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 |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C |
| Packaging | Box, carton |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CCX CO-OX | In distribution | |
| pHOx/BASIC/PLUS/L/C | In distribution | |
| phox Ultra/CCX | In distribution | |
| PHOX PLUS | In distribution | |
| PLUS/L/C | In distribution | |
| PRIME CCS COMP | In distribution | |
| Prime CCS Comp | In distribution | |
| PHOX ULTRA | In distribution | |
| pHOx Ultra/CCX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Calcium Electrode | Medica Corp. | 2 |
| SC90 | Radiometer Medical APS | 2 |
| pH/pCO2/pO2/Na/K/Ca Analyzer | Medica Corp. | 2 |
| Na/K/Cl/Ca/Li Solution pack | Medica Corp. | 1 |
| Rinse Solution S4980 REF 944-130 | Radiometer Medical APS | 1 |
| Nova/Stat Profile | Nova Biomedical Corporation | 1 |
| Rapidpoint® 350 Sampler Module | Siemens Healthcare Diagnostics Inc | 1 |
| RAPIDLab® 1200 pH Electrode Fill | Siemens Healthcare Diagnostics Inc | 1 |
| Roche 9180 Electrolyte Analyzer | Roche Diagnostics Gmbh | 1 |
| E-Ca Cassette Carton | Opti Medical Systems Inc. | 1 |
| Calcium Reference Electrode | Medica Corp. | 1 |
Showing 12 of 33. All products under Electrode, Ion Specific, Calcium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191626 | 2019-08-16 |
| K960120 | 1996-03-11 |
| K830213 | 1983-04-05 |
| K830502 | 1983-03-24 |
| K823389 | 1983-02-02 |
| K771643 | 1977-09-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | 510(k) number | 2017-06-19 | Class II | Software design | Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results. | 179 units (US) and 904 (OUS) Total 1083 | 2018-08-14 |
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.