DEVICE: Stat Profile (00385480485890)

Device Identifier (DI) Information

Stat Profile
pHOx Ultra/CCX
In Commercial Distribution
48589
NOVA BIOMEDICAL CORPORATION
00385480485890
GS1

250
070617139 *Terms of Use
Stat Profile pHOx Ultra/CCX Capillary Tube 115 uL with Na Heparin 250 per Vial
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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
CGA GLUCOSE OXIDASE, GLUCOSE
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
NGD TEST, LACTIC ACID, OVER THE COUNTER
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
GHS ASSAY, CARBOXYHEMOGLOBIN
GLY OXIMETER TO MEASURE HEMOGLOBIN
BXX CALIBRATOR, PRESSURE, GAS
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JGS ELECTRODE, ION SPECIFIC, SODIUM
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
GKK CYANOMETHEMOGLOBIN
GJC ASSAY, SULFHEMOGLOBIN
GGZ OXYHEMOGLOBIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110648 000
No CLOSE

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

86a53277-7dd0-41f9-b5b9-455782d0cb98
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

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

[?]
Unit of Use DI Number: 00385489485891 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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