DEVICE: STAT PROFILE (00385480215190)
Device Identifier (DI) Information
STAT PROFILE
PHOX
In Commercial Distribution
21519
NOVA BIOMEDICAL CORPORATION
PHOX
In Commercial Distribution
21519
NOVA BIOMEDICAL CORPORATION
STAT PROFILE pHOx PROBE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Blood gas/haemoximetry 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 measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
JPK | MIXTURE, HEMATOLOGY QUALITY CONTROL |
JPI | DEVICE, HEMATOCRIT MEASURING |
GKR | SYSTEM, HEMOGLOBIN, AUTOMATED |
JKS | Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide |
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K014295 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0a104659-010b-40f8-9641-c4ccb37487f3
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 |
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No Package DIs found |
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(180)054-5668
info@novabio.com
info@novabio.com