Home GUDID 00385480420181 STAT PROFILE
Primary DI 00385480420181
Brand STAT PROFILE
Company NOVA BIOMEDICAL CORPORATION
Model PHOX ULTRA
Catalog number 42018
Device description Remanufactured Stat Profile pHOx Ultra Analyzer
Published 2016-09-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name BXX CALIBRATOR, PRESSURE, GAS CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN CEM ELECTRODE, ION SPECIFIC, POTASSIUM CFA ELECTRODE, ION SPECIFIC, MAGNESIUM CGA GLUCOSE OXIDASE, GLUCOSE CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH GGZ OXYHEMOGLOBIN GHS ASSAY, CARBOXYHEMOGLOBIN GJC ASSAY, SULFHEMOGLOBIN GKK CYANOMETHEMOGLOBIN GLY OXIMETER TO MEASURE HEMOGLOBIN JFP ELECTRODE, ION SPECIFIC, CALCIUM JGS ELECTRODE, ION SPECIFIC, SODIUM JIX CALIBRATOR, MULTI-ANALYTE MIXTURE JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) NGD TEST, LACTIC ACID, OVER THE COUNTER
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BXX Calibrator, Pressure, Gas Anesthesiology 1 CDS Electrode, Ion Specific, Urea Nitrogen Clinical Chemistry 2 CEM Electrode, Ion Specific, Potassium Clinical Chemistry 2 CFA Electrode, Ion Specific, Magnesium Clinical Chemistry 1 CGA Glucose Oxidase, Glucose Clinical Chemistry 2 CGL Electrode, Ion Based, Enzymatic, Creatinine Clinical Chemistry 2 CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry 2 CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph Clinical Chemistry 2 GGZ Oxyhemoglobin Hematology 2 GHS Assay, Carboxyhemoglobin Hematology 2 GJC Assay, Sulfhemoglobin Hematology 2 GKK Cyanomethemoglobin Hematology 2 GLY Oximeter To Measure Hemoglobin Hematology 2 JFP Electrode, Ion Specific, Calcium Clinical Chemistry 2 JGS Electrode, Ion Specific, Sodium Clinical Chemistry 2 JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry 2 JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry 1 NGD Test, Lactic Acid, Over The Counter Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10385480420188 Package GS1 1 In Commercial Distribution 00385480420181 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10385480420188 10385480420188 00385480420181 00385480420181 385480420181 0385480420181
GMDN Terms# Term, Definition table Term Definition Metabolic profile clinical chemistry analyser IVD, portable, semi-automated A portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 15 Degrees Celsius 30 Degrees Celsius Special Storage Condition, Specify 0 0 0 ft to 15000 ft Special Storage Condition, Specify 0 0 Without Condensation Storage Environment Humidity 20 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 070617139 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06935740751773 Urine Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751780 URINE REAGENT STRIPS Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751797 URINE REAGENT STRIPS Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751803 Urine Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751810 Urine Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751827 URINE REAGENT STRIPS Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751834 Urine Strips Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751841 Urine Analyzer Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751858 Urine Analyzer Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751865 URINE ANALYZER Urit Medical Electronic Co., Ltd. JJB 2026-06-03 06935740751872 URINE ANALYZER Urit Medical Electronic Co., Ltd. JJB 2026-06-03 08806141303497 One+Step 10A DFI CO.,LTD JJB 2023-10-16 08430793040518 Aptiva® Celiac Disease IgG Calibrators INOVA DIAGNOSTICS, INC. JIX 2022-05-27 08430793040570 Aptiva® Celiac Disease IgA Calibrators INOVA DIAGNOSTICS, INC. JIX 2022-05-27 08806141302209 Just Fitter 10 Parameter Test Strips DFI CO.,LTD JJB 2020-09-22 08809301160862 Pip Blood Glucose Monitoring System PHILOSYS Co., Ltd CGA 2020-09-11 08806141302070 CYBOW 10 DFI CO.,LTD JJB 2020-06-29 08806141301998 Yodoc 10 DFI CO.,LTD JJB 2020-02-20 08806141301479 QTEST™ 11 DFI CO.,LTD JJB 2018-12-21 08058056680532 Plasmaproteins Cal 3x SENTINEL CH. SPA JIX 2018-11-15 08809301160411 Gmate Smart Blood Glucose Monitoring System PHILOSYS Co., Ltd CGA 2018-09-17 08426950807544 GEM Premier 5000 PAK BG/COOX/TBILI 75 TEST INSTRUMENTATION LABORATORY COMPANY GLY 2018-01-24 08426950807544 GEM Premier 5000 PAK BG/COOX/TBILI 75 TEST INSTRUMENTATION LABORATORY COMPANY GHS 2018-01-24 08426950807568 GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST INSTRUMENTATION LABORATORY COMPANY GLY 2018-01-24 08426950807568 GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST INSTRUMENTATION LABORATORY COMPANY GHS 2018-01-24 08426950807575 GEM Premier 5000 PAK BG/ISE/COOX 600 TEST INSTRUMENTATION LABORATORY COMPANY JFP 2018-01-24 08426950807575 GEM Premier 5000 PAK BG/ISE/COOX 600 TEST INSTRUMENTATION LABORATORY COMPANY CGZ 2018-01-24 08426950807575 GEM Premier 5000 PAK BG/ISE/COOX 600 TEST INSTRUMENTATION LABORATORY COMPANY CEM 2018-01-24 08426950807575 GEM Premier 5000 PAK BG/ISE/COOX 600 TEST INSTRUMENTATION LABORATORY COMPANY GLY 2018-01-24 08426950807575 GEM Premier 5000 PAK BG/ISE/COOX 600 TEST INSTRUMENTATION LABORATORY COMPANY JGS 2018-01-24
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