Epoc Host2
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or…
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions.
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 | Epocal, Inc., Canada |
|---|---|
| FDA product code | JFP |
| Device type | Electrode, Ion Specific, Calcium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1145 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K061597 |
| Record published | 2020-07-15 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 0 to 85 % RH; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11413524 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 9 |
| 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 |
Showing 12 of 33. All products under Electrode, Ion Specific, Calcium
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2022-12-12 | Class II | Under Investigation by firm | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | 22,156 units | |
| Epocal, Inc. | 510(k) number | 2013-03-13 | Class II | Nonconforming Material/Component | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). S | 828,750 Test Card | 2016-08-31 |
| Epocal, Inc. | 510(k) number | 2011-06-28 | Class II | Device Design | Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (appr | 8,650 | 2013-12-18 |
| Epocal, Inc. | 510(k) number | 2008-10-16 | Not classified | Other | elevated range of potassium levels | 1000 test cards | 2009-02-06 |
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.