DEVICE: STAT PROFILE (00385480485678)

Device Identifier (DI) Information

STAT PROFILE
PHOX ULTRA/CCX
In Commercial Distribution
48567
NOVA BIOMEDICAL CORPORATION
00385480485678
GS1

1
070617139 *Terms of Use
STAT PROFILE PHOX ULTRA/CCX CALIBRATOR TUBING
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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
JGS ELECTRODE, ION SPECIFIC, SODIUM
GKK CYANOMETHEMOGLOBIN
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
GLY OXIMETER TO MEASURE HEMOGLOBIN
GJC ASSAY, SULFHEMOGLOBIN
GGZ OXYHEMOGLOBIN
GHS ASSAY, CARBOXYHEMOGLOBIN
CGA GLUCOSE OXIDASE, GLUCOSE
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
NGD TEST, LACTIC ACID, OVER THE COUNTER
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
BXX CALIBRATOR, PRESSURE, GAS
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
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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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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

09d7bddf-3a1a-463d-9a94-5d9e8c07f912
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
No Package DIs found
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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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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