DEVICE: STAT PROFILE (00385480485623)

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Device Record History
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Device Identifier (DI) Information
STAT PROFILE
PHOX ULTRA
In Commercial Distribution
48562
NOVA BIOMEDICAL CORPORATION
00385480485623
GS1

1
070617139 *Terms of Use
Stat Profile pHOx Ultra Co-Oximeter S-Line Probe Assembly
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
56668 Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
A portable mains electricity (AC-powered) laboratory instrument, which may include internal rechargeable batteries, 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 in addition 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.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JJB AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
GGZ OXYHEMOGLOBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
NGD TEST, LACTIC ACID, OVER THE COUNTER
GHS ASSAY, CARBOXYHEMOGLOBIN
CGA GLUCOSE OXIDASE, GLUCOSE
GJC ASSAY, SULFHEMOGLOBIN
GKK CYANOMETHEMOGLOBIN
GLY OXIMETER TO MEASURE HEMOGLOBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
BXX CALIBRATOR, PRESSURE, GAS
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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
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
9490ff6e-475c-4a16-997d-d031b80c977d
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
10385480485620 1 00385480485623 In Commercial Distribution carton
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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

[?]
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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