DEVICE: STAT PROFILE (00385480420433)

Device Identifier (DI) Information

STAT PROFILE
PRIME
In Commercial Distribution
42043
NOVA BIOMEDICAL CORPORATION
00385480420433
GS1

1
070617139 *Terms of Use
Prime Reference Cartridge
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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
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
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FDA Product Code

[?]
Product Code Product Code Name
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
JGS ELECTRODE, ION SPECIFIC, SODIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JJS CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
CGA GLUCOSE OXIDASE, GLUCOSE
GKF INSTRUMENT, HEMATOCRIT, AUTOMATED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141907 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

15723fae-1357-49e8-88bf-8afae26d2008
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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