DEVICE: STAT PROFILE (00385480420174)

Device Identifier (DI) Information

STAT PROFILE
PHOX ULTRA CO OX
In Commercial Distribution
42017
NOVA BIOMEDICAL CORPORATION
00385480420174
GS1

1
070617139 *Terms of Use
Remanufactured Stat Profile pHOx Ultra CO-Oximeter 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
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at point-of-care in acute care settings, 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 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.
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FDA Product Code

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Product Code Product Code Name
CGA GLUCOSE OXIDASE, GLUCOSE
NGD TEST, LACTIC ACID, OVER THE COUNTER
GJC ASSAY, SULFHEMOGLOBIN
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
GLY OXIMETER TO MEASURE HEMOGLOBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GGZ OXYHEMOGLOBIN
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
BXX CALIBRATOR, PRESSURE, GAS
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
GHS ASSAY, CARBOXYHEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
GKK CYANOMETHEMOGLOBIN
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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

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Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: 0 ft to 15000 ft
Special Storage Condition, Specify: Without Condensation
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

c6b77035-1c21-476c-b038-ff4c238eace5
July 06, 2018
3
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10385480420171 1 00385480420174 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

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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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