DEVICE: STAT PROFILE (00385480420143)
Device Identifier (DI) Information
STAT PROFILE
PHOX ULTRA
In Commercial Distribution
42014
NOVA BIOMEDICAL CORPORATION
PHOX ULTRA
In Commercial Distribution
42014
NOVA BIOMEDICAL CORPORATION
Stat Profile pHOx Ultra ABG Analyzer
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
56671 | Blood gas analyser IVD, point-of-care |
A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
CFA | ELECTRODE, ION SPECIFIC, MAGNESIUM |
GGZ | OXYHEMOGLOBIN |
CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
GLY | OXIMETER TO MEASURE HEMOGLOBIN |
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
GKK | CYANOMETHEMOGLOBIN |
CDS | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
JJB | AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.) |
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
NGD | TEST, LACTIC ACID, OVER THE COUNTER |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
CGA | GLUCOSE OXIDASE, GLUCOSE |
BXX | CALIBRATOR, PRESSURE, GAS |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
GJC | ASSAY, SULFHEMOGLOBIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110648 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: 0 ft to 15000 ft |
Special Storage Condition, Specify: Without Condensation |
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6d42a07c-cd6d-43cd-9040-1bbd242b322d
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10385480420140 | 1 | 00385480420143 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com