DEVICE: MAXO2 ME (00853061006951)

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Device Record History
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Device Identifier (DI) Information
MAXO2 ME
R230P01
In Commercial Distribution
R230P01
MAXTEC, LLC
00853061006951
GS1

1
169911828 *Terms of Use
AIr/Oxygen Medical Gas Monitor
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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No

GMDN

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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?
35219 Respiratory oxygen monitor, line-powered
A mains electricity (AC-powered) instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range; it may also include appropriate temperature-compensated electrodes.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K153659 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 Atmospheric Pressure: between 800 and 1013 millibar
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 122 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
09bacd53-f024-46f9-a300-51c00a7596bf
December 21, 2018
4
July 05, 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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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