Stat Profile
Stat Profile Prime Calibrator Flush Fixture
2manufacturers in China registered for this device type
14catalogue numbers in this listing
2510(k) clearances naming this product 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 | CGZ |
| Device type | Electrode, Ion-Specific, Chloride |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1170 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K141907 |
| Record published | 2016-09-20 |
| Record revised | 2022-09-16 (version 4) |
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, carton of 4, carton of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRIME | In distribution | |
| CCX | In distribution | |
| PRIME | In distribution | |
| CCX | In distribution | |
| PHOX plus/L/C | In distribution | |
| ULTRA/CCX | In distribution | |
| PHOX PLUS/C | In distribution | |
| PRIME | In distribution | |
| PLUS/L/C | In distribution | |
| PRIME CSS | In distribution | |
| PRIME CCS | In distribution | |
| PRIME CCS | In distribution | |
| pHOx/BASIC/PLUS/L/C | In distribution | |
| PHOX ULTRA S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Architect | Abbott Laboratories | 6 |
| Chloride Electrode | Roche Diagnostics Gmbh | 3 |
| Chloride Electrode | Medica Corp. | 3 |
| Chloride Electrode | Diamond Diagnostics Inc. | 3 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| I.S.E. CL | Randox Laboratories Limited | 2 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| Na/K/Cl Solution Pack | Medica Corp. | 2 |
| Ready Sensor™ Gold Reference Sensor Refill | Siemens Healthcare Diagnostics Inc | 1 |
| I.S.E. REF | Randox Laboratories Limited | 1 |
| ABL90 Flex Plus | Radiometer Medical APS | 1 |
Showing 12 of 51. All products under Electrode, Ion-Specific, Chloride
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K924864 | 1992-11-06 |
| K912561 | 1991-09-11 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, 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 |
| Nova Biomedical Corporation | 510(k) number | 2006-01-27 | Not classified | Other | Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs | 498 units | 2006-10-19 |
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.