FDA.report

MVB2

Primary DI
00850021133221
Brand
MVB2
Company
CAVAGNA GROUP SPA
Model
MVB2
Catalog number
MVB2UOS001
Device description
Valve for Medical O2
Published
2023-06-19
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
00850021133221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021133221008500211332218500211332210850021133221

GMDN Terms

TermDefinition
Fixed medical gas cylinder regulatorA 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.

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-40 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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