Stat Profile
Stat Profile pHOx Ultra/CCX Sensor Multi blank
2manufacturers in China registered for this device type
13catalogue numbers in this listing
21510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Nova Biomedical Corporation, United States |
|---|---|
| FDA product code | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K002613 |
| Record published | 2016-09-20 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PHOS PLUS/L/C | In distribution | |
| PHOX ULTRA/CCX | In distribution | |
| Prime Plus | In distribution | |
| PLUS/L/C | In distribution | |
| ULTRA/CCX | In distribution | |
| PRIME CCS | In distribution | |
| pHOx | In distribution | |
| phox Ultra/CCX | In distribution | |
| pHOx Ultra/CCX | In distribution | |
| CCX | In distribution | |
| Prime Plus | In distribution | |
| PHOX | In distribution | |
| phox Ultra/CCX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| i-STAT | Abbott Point OF Care Inc. | 9 |
| AU | Beckman Coulter, Inc. | 8 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 2 |
| Sodium Electrode | Medica Corp. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200403 | 2020-04-14 |
| K191365 | 2019-07-19 |
| K180428 | 2018-08-15 |
| K001761 | 2000-08-07 |
| K000895 | 2000-04-17 |
| K924547 | 1993-01-28 |
| K923806 | 1992-09-29 |
| K921937 | 1992-07-27 |
| K922215 | 1992-07-17 |
| K915176 | 1992-01-15 |
| K912560 | 1991-07-17 |
| K912559 | 1991-07-01 |
| K905264 | 1991-03-05 |
| K894218 | 1989-09-07 |
| K880750 | 1988-07-01 |
| K881255 | 1988-05-16 |
| K874832 | 1988-02-11 |
| K872190 | 1987-06-24 |
| K811289 | 1981-05-27 |
| K801882 | 1980-09-16 |
| K770601 | 1977-06-14 |
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 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-09-18 | Class II | Process design | Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be id | 161 units |
| 2023-09-18 | Class II | Process design | Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be id | 1779 units: 438 US; 1341 OUS |
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.