DEVICE: STAT PROFILE (00385480340816)

Device Identifier (DI) Information

STAT PROFILE
PHOX PLUS L
In Commercial Distribution
34081
NOVA BIOMEDICAL CORPORATION
00385480340816
GS1

1
070617139 *Terms of Use
Stat Profile pHOx Plus L 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
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at point-of-care in acute care settings, intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with reduced technician involvement and automation of some procedural steps.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K012058 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 Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Without Condensation
Special Storage Condition, Specify: 0 ft to 15000 ft
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

5c1465bc-4254-4e13-8965-abe03497d356
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
10385480340813 1 00385480340816 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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