Stat Profile
Stat Profile Prime Plus Calibrator Cartridge 400 Sample with Creat / BUN
1manufacturer
80catalogue numbers in this listing
28510(k) clearances naming this product code
11recalls on this 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 | CHL |
| Device type | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1120 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K014295 |
| 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 |
| Supplied as a kit | Yes |
| 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 2 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| PRIME ABG | In distribution | ||
| PRIME ABG | In distribution | ||
| PHOX/BASIC/PLUS/L/C | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| phox Ultra/CCX | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| PHOX/BASIC/PLUS/L/C | 3 | In distribution | |
| ULTRA/CCX | 3 | In distribution | |
| Prime ES Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime ES | 20 | In distribution | |
| Prime Plus | 30 | In distribution | |
| Prime ES Comp Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| 3 | 100 | In distribution | |
| Prime ES Plus | In distribution | ||
| PHOX/BASIC/PLUS/L/C | 3 | In distribution | |
| Prime ABG | In distribution | ||
| Prime Plus | 30 | In distribution | |
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| PRIME ABG | In distribution | ||
| Prime ES Plus | In distribution | ||
| PHOX/BASIC/PLUS/L/C | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| phox Ultra/CCX | In distribution | ||
| Prime | In distribution | ||
| Prime ES Plus | In distribution | ||
| pHOx/BASIC/PLUS/L/C | In distribution | ||
| ULTRA | 4 | In distribution | |
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime | In distribution | ||
| PHOX ULTRA | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| M/2/3 | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Comp Plus | In distribution | ||
| PHOX PLUS | In distribution | ||
| Prime Plus | In distribution | ||
| 1 | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime Plus | In distribution | ||
| Prime Plus | In distribution | ||
| ULTRA | 4 | In distribution | |
| ULTRA | 8 | In distribution | |
| phox Ultra/CCX | In distribution | ||
| PRIME | In distribution | ||
| Prime ES Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| PHOX/BASIC/PLUS/L/C | In distribution | ||
| Prime | In distribution | ||
| Prime Plus | In distribution | ||
| Prime ES Plus | In distribution | ||
| PHOX ULTRA/CCX | 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ABL80 SC80 | Radiometer Medical APS | 66 |
| ABL77 Sci | Radiometer Medical APS | 14 |
| Electrode for ABL analyzers | Radiometer Medical APS | 7 |
| Calibration Solution | Radiometer Medical APS | 7 |
| i-STAT | Abbott Point OF Care Inc. | 6 |
| ABL90 Sensor Cassette pack | Radiometer Medical APS | 6 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX/Tbili 450 Tests) | Instrumentation Laboratory SPA | 5 |
| Nova | Nova Biomedical Corporation | 4 |
| GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests) | Instrumentation Laboratory SPA | 4 |
| Calibration Gas 2 | Radiometer Medical APS | 3 |
| Ready Sensor™ Lactate Biosensor | Siemens Healthcare Diagnostics Inc | 3 |
| Calibration gas 1 | Radiometer Medical APS | 3 |
Showing 12 of 235. All products under Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221900 | 2023-09-29 |
| K193246 | 2020-01-24 |
| K173797 | 2018-07-17 |
| K151982 | 2015-09-10 |
| K141907 | 2015-05-29 |
| K142220 | 2014-10-17 |
| K131703 | 2014-03-25 |
| K110648 | 2011-08-29 |
| K023567 | 2002-12-20 |
| K022746 | 2002-11-22 |
| K021713 | 2002-07-25 |
| K020297 | 2002-06-10 |
| K014295 | 2002-02-28 |
| K013729 | 2002-01-15 |
| K012058 | 2001-08-20 |
| K002613 | 2000-10-19 |
| K982277 | 1998-07-22 |
| K980991 | 1998-04-15 |
| K970710 | 1997-05-09 |
| K954711 | 1995-11-30 |
| K936203 | 1995-03-09 |
| K943643 | 1994-12-29 |
| K924497 | 1993-02-23 |
| K884143 | 1988-12-02 |
| K871397 | 1987-06-03 |
| K864445 | 1987-02-04 |
| K854608 | 1985-12-05 |
| K852790 | 1985-11-12 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | UDI-DI | 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 | |
| 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
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 2006-01-27 | Not classified | Other | Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs | 33 units | 2006-10-19 |
| 2006-01-27 | Not classified | Other | Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs | 408 units | 2006-10-19 |
| 2004-03-30 | Not classified | Other | Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems | 30 units | 2004-06-17 |
| 2004-03-30 | Not classified | Other | Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems | 35 units | 2004-06-17 |
| 2004-03-30 | Not classified | Other | Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems | 7units | 2004-06-17 |
| 2004-03-30 | Not classified | Other | Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems | 3 units | 2004-06-17 |
| 2004-03-30 | Not classified | Other | Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems | 5 units | 2004-06-17 |
| 2003-09-22 | Not classified | Other | Degradation of the magnesium sensor could result in low ionozed magnesium patient samples | 659 units | 2004-02-04 |
| 2003-09-22 | Not classified | Other | Degradation of the magnesium sensor could result in low ionozed magnesium patient samples | 280 units | 2004-02-04 |
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.