DEVICE: STAT PROFILE (00385480230230)

Device Identifier (DI) Information

STAT PROFILE
pHOx/BASIC/PLUS/L/C
In Commercial Distribution
23023
NOVA BIOMEDICAL CORPORATION
00385480230230
GS1

1
070617139 *Terms of Use
STAT PROFILE pHOx PLUS/L/C/M W/R Pump Tubing 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?
56672 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM
CFA ELECTRODE, ION SPECIFIC, MAGNESIUM
JPI DEVICE, HEMATOCRIT MEASURING
KHP ACID, LACTIC, ENZYMATIC METHOD
JKS Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

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

59057950-d054-4fe1-982c-2dbf2e6c6a5b
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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