Stat Profile
STAT PROFILE/M/ULTRA CAPILLARY TUBE KIT: 250uL WITH Li HEPARIN
2manufacturers in China registered for this device type
7catalogue numbers in this listing
4510(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 | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| 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 | Special storage condition: 0 ft to 15000 ft; Handling environment temperature 15 to 30 °C; Storage environment temperature 15 to 30 °C; Special storage condition: Without Condensation; Storage environment humidity 0 to 85 % RH |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PHOX PLUS | In distribution | ||
| PRIME CCS COMP | In distribution | ||
| PLUS/L/C | In distribution | ||
| PHOX ULTRA | In distribution | ||
| PRIME | In distribution | ||
| phox Ultra/CCX | In distribution | ||
| ULTRA | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Potassium electrode | Roche Diagnostics Gmbh | 4 |
| Potassium Electrode | Diamond Diagnostics Inc. | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Architect | Abbott Laboratories | 3 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| I.S.E. K | Randox Laboratories Limited | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Potassium Electrode | Medica Corp. | 2 |
| Na/K Solution Pack | Medica Corp. | 2 |
| Selectra | VitalScientific B.V. | 2 |
| FlexLab | Inpeco SA | 1 |
Showing 12 of 93. All products under Electrode, Ion Specific, Potassium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922943 | 1992-10-13 |
| K915178 | 1992-01-27 |
| K915177 | 1992-01-27 |
| K791175 | 1979-08-10 |
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.