DEVICE: STAT PROFILE (00385480534185)

Device Identifier (DI) Information

STAT PROFILE
PRIME CCS
In Commercial Distribution
53418
NOVA BIOMEDICAL CORPORATION
00385480534185
GS1

1
070617139 *Terms of Use
Remanufacture PRIME CCS 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

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

FDA Premarket Submission Number [?] Supplement Number [?]
K141907 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
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Storage Environment Temperature: between 15 and 32 Degrees Celsius
Special Storage Condition, Specify: Without Condensation
Special Storage Condition, Specify: 0 ft to 12000 ft
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

17b295c0-cd7d-4f59-a3f9-58aefa9d25dc
July 06, 2018
3
July 06, 2017
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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
10385480534182 1 00385480534185 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

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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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

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