DEVICE: Stat Profile (00385480492058)

Device Identifier (DI) Information

Stat Profile
pHOx Ultra/CCX
In Commercial Distribution
49205
NOVA BIOMEDICAL CORPORATION
00385480492058
GS1

1
070617139 *Terms of Use
Stat Profile pHOx Ultra/CCX Sensor Multi blank
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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

[?]
Product Code Product Code Name
JGS ELECTRODE, ION SPECIFIC, SODIUM
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
GGZ OXYHEMOGLOBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GLY OXIMETER TO MEASURE HEMOGLOBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
NGD TEST, LACTIC ACID, OVER THE COUNTER
GKK CYANOMETHEMOGLOBIN
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
GJC ASSAY, SULFHEMOGLOBIN
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
BXX CALIBRATOR, PRESSURE, GAS
CGA GLUCOSE OXIDASE, GLUCOSE
GHS ASSAY, CARBOXYHEMOGLOBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
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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
No storage/handling found
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Clinically Relevant Size

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

edbed0cf-53e8-4d18-8c5a-426c2477714d
July 06, 2018
3
September 16, 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

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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