DEVICE: Stat Profile (00385480489546)

Device Identifier (DI) Information

Stat Profile
pHOx Ultra/CCX
In Commercial Distribution
48954
NOVA BIOMEDICAL CORPORATION
00385480489546
GS1

1
070617139 *Terms of Use
TUBING ASSEMBLIES L1,L2,L3 STP PHOX ULTRA/CCX
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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

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

[?]
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

8e050ffb-7445-4fe8-ab63-b1aaab52ad4e
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: 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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