DEVICE: STAT PROFILE (00385480374132)

Device Identifier (DI) Information

STAT PROFILE
CCX CO OX
In Commercial Distribution
37413
NOVA BIOMEDICAL CORPORATION
00385480374132
GS1

1
070617139 *Terms of Use
Stat Profile Critical Care Express CO-Oximeter Analyzer
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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
Co-oximetry analyser IVD, point-of-care A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).
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FDA Product Code

[?]
Product Code Product Code Name
JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
CGA GLUCOSE OXIDASE, GLUCOSE
CIG DIAZO COLORIMETRY, BILIRUBIN
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
CDS ELECTRODE, ION SPECIFIC, UREA NITROGEN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JPI DEVICE, HEMATOCRIT MEASURING
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JJY Multi-analyte controls, all kinds (assayed)
JPK MIXTURE, HEMATOLOGY QUALITY CONTROL
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
KHP ACID, LACTIC, ENZYMATIC METHOD
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
GHS ASSAY, CARBOXYHEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
JIT CALIBRATOR, SECONDARY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K061830 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: 0 ft to 15000 ft
Special Storage Condition, Specify: Without Condensation
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

00aaa5ed-7c03-404c-838c-0e5c1382bbd1
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
10385480374139 1 00385480374132 In Commercial Distribution Box
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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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

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