DEVICE: Beamer AVEO (30653405988636)
Device Identifier (DI) Information
Beamer AVEO
AVEO-2
In Commercial Distribution
AVEO-2
Conmed Corporation
AVEO-2
In Commercial Distribution
AVEO-2
Conmed Corporation
Beamer AVEO Argon Pressure Reducer CGA, No. 580
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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? |
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43438 | Non-fixed medical gas cylinder regulator |
A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.
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FDA Product Code
[?]Product Code | Product Code Name |
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CAN | Regulator, pressure, gas cylinder |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 594 and 1060 millibar |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight |
Handling Environment Atmospheric Pressure: between 617 and 1060 millibar |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e45ead46-6fde-4944-9b5c-a11d58967feb
January 08, 2025
1
December 31, 2024
January 08, 2025
1
December 31, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)426-6633
CustomerExperience@conmed.com
CustomerExperience@conmed.com