FDA.report

MVA1 Viproxy

Primary DI
00850021133016
Brand
MVA1 Viproxy
Company
CAVAGNA GROUP SPA
Model
MVA1 Viproxy
Catalog number
MVA1MMX007
Device description
Valve with Integrated Pressure Regulator for Medical Gas
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications

CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850021133016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021133016008500211330168500211330160850021133016

GMDN Terms

TermDefinition
Respiratory oxygen therapy systemAn 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.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure600 millibar1200 millibar
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius65 Degrees Celsius
Storage Environment Atmospheric Pressure600 millibar1200 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-65 Degrees Celsius65 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
436289300
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00850021133221MVB2MVB2MVB2UOS0012023-06-19
00850021133009MVA1 ViproxyMVA1 ViproxyMVA1MMX0052020-08-03
00850021133023MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UOS0012020-08-03
00850021133030MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UOS0022020-08-03
00850021133047MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UOS0102020-08-03
00850021133054MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UOS0112020-08-03
00850021133061MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UOS0122020-08-03
00850021133078MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UMX0012020-08-03
00850021133085MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UMX0022020-08-03
00850021133092MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2UAI0012020-08-03
00850021133108MVA2 Viproxy 1 TouchMVA2 Viproxy 1 TouchMVA2EOS037 2020-08-03

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