DEVICE: STAT PROFILE (00385480214971)

Device Identifier (DI) Information

STAT PROFILE
pHOx/BASIC/PLUS/L/C
In Commercial Distribution
21497
NOVA BIOMEDICAL CORPORATION
00385480214971
GS1

1
070617139 *Terms of Use
STAT PROFILE pHOx/BASIC/PLUS/L/C REFERENCE LINE ASSEMBLY
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blood gas/haemoximetry analyser IVD, point-of-care A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
JPK MIXTURE, HEMATOLOGY QUALITY CONTROL
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JPI DEVICE, HEMATOCRIT MEASURING
KHP ACID, LACTIC, ENZYMATIC METHOD
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
GJS TEST, TIME, PROTHROMBIN
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K014295 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e3967637-9e1f-4c8e-a345-2a5619be7856
July 06, 2018
3
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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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