DEVICE: MVA2 Viproxy 1 Touch (00850021133023)
Device Identifier (DI) Information
MVA2 Viproxy 1 Touch
MVA2 Viproxy 1 Touch
In Commercial Distribution
MVA2UOS001
CAVAGNA GROUP SPA
MVA2 Viproxy 1 Touch
In Commercial Distribution
MVA2UOS001
CAVAGNA GROUP SPA
Valve with Integrated Pressure Regulator for Medical Gas
Device Characteristics
MR Conditional | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
37498 | Respiratory oxygen therapy system |
An assembly of devices designed to be interconnected to administer oxygen (O2) to a patient using various methods of oxygen administration (e.g., face mask, nasal canula) at different concentrations (e.g., via a gas mixer), duration of use, and flows. It will connect to an oxygen source and will typically include a flowmeter or flow controlling device, masks, tubing, valves, and/or nasal cannulae. It can also include, e.g., a high pressure gas reduction valve(s) and a pneumatically-powered suction device with collection bottle.
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Obsolete | false |
60970 | Fixed medical gas cylinder regulator |
A gas-regulating component 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. It typically includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.
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Active | false |
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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Active | false |
31760 | Fixed-regulator oxygen refillable cylinder |
A container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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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Handling Environment Atmospheric Pressure: between 600 and 1200 millibar |
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity |
Handling Environment Temperature: between -25 and 65 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 600 and 1200 millibar |
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 65 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
10da89e5-3f96-4b57-b41f-de3bb9911aff
February 20, 2023
3
August 03, 2020
February 20, 2023
3
August 03, 2020
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
[?]
No Customer Contact currently defined