DEVICE: Cavagna (00850009834041)
Device Identifier (DI) Information
Cavagna
VIPROXY 1 Touch
In Commercial Distribution
MVA2UOS002
CAVAGNA NORTH AMERICA INC
VIPROXY 1 Touch
In Commercial Distribution
MVA2UOS002
CAVAGNA NORTH AMERICA INC
Gas Cylinder Pressure Regulator. Analog pressure indicator
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? |
---|---|---|---|---|
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.
|
Active | 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.
|
Active | false |
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.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAN | Regulator, Pressure, Gas Cylinder |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -40 and 65 Degrees Celsius |
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 600 and 1200 millibar |
Handling Environment Temperature: between -20 and 65 Degrees Celsius |
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 600 and 1200 millibar |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
def50d73-47f6-44dd-8782-0f25c0ddc6c4
February 20, 2023
4
July 31, 2019
February 20, 2023
4
July 31, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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 (732) 469-2100
info@cavagna.com
info@cavagna.com