DEVICE: STAT PROFILE (00385480420143)

Device Identifier (DI) Information

STAT PROFILE
PHOX ULTRA
In Commercial Distribution
42014
NOVA BIOMEDICAL CORPORATION
00385480420143
GS1

1
070617139 *Terms of Use
Stat Profile pHOx Ultra ABG Analyzer
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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 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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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110648 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6d42a07c-cd6d-43cd-9040-1bbd242b322d
July 06, 2018
3
September 20, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)545-6682
info@novabio.com
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