DEVICE: STAT PROFILE (00385480420181)

Device Identifier (DI) Information

STAT PROFILE
PHOX ULTRA
In Commercial Distribution
42018
NOVA BIOMEDICAL CORPORATION
00385480420181
GS1

1
070617139 *Terms of Use
Remanufactured Stat Profile pHOx Ultra 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
GHS ASSAY, CARBOXYHEMOGLOBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
NGD TEST, LACTIC ACID, OVER THE COUNTER
GJC ASSAY, SULFHEMOGLOBIN
GLY OXIMETER TO MEASURE HEMOGLOBIN
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
CGA GLUCOSE OXIDASE, GLUCOSE
JGS ELECTRODE, ION SPECIFIC, SODIUM
GGZ OXYHEMOGLOBIN
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
GKK CYANOMETHEMOGLOBIN
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
BXX CALIBRATOR, PRESSURE, GAS
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
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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
Special Storage Condition, Specify: Without Condensation
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: 0 ft to 15000 ft
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

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Size Type Text
No Device Sizes
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Device Record Status

aae0a284-ae8d-4dd3-96af-25ea9b05aaa8
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
10385480420188 1 00385480420181 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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