DEVICE: STAT PROFILE (00385480355407)

Device Identifier (DI) Information

STAT PROFILE
PHOX BASIC
In Commercial Distribution
35540
NOVA BIOMEDICAL CORPORATION
00385480355407
GS1

1
070617139 *Terms of Use
Remanufactured Stat Profile Phox Basic 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
Blood gas 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 calculation of other blood gas parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient] in a clinical specimen.
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FDA Product Code

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Product Code Product Code Name
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
JPK MIXTURE, HEMATOLOGY QUALITY CONTROL
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K013729 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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Without Condensation
Special Storage Condition, Specify: 0 ft to 15000 ft
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

1b32430a-28b3-4a56-83e8-7bf2b14c52bf
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
10385480355404 1 00385480355407 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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