FDA.reportPublic FDA data

MS25 O2 PI DN _ 9/16 G

Primary DI
08592346786530
Brand
MS25 O2 PI DN _ 9/16 G
Company
GCE, s.r.o.
Model
0720108US
Device description
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
Published
2022-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
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
08592346786530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08592346786530085923467865308592346786530

GMDN Terms

TermDefinition
Non-fixed medical gas cylinder regulatorA 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 mixtures) cylinder to lower 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
819753190
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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08592346893399Varimed+VM+ O2 CGA540 _ _ 9/16 S0729114US2025-03-17
08592346893405VarimedVM O2 CGA870 _ _ 9/16 S0729115US2025-03-17
08592346893412Varimed+VM+ O2 CGA870 _ _ 9/16 S0729116US2025-03-17
08592346893429VarimedVM AIR CGA346 _ _ 9/16 S0729117US2025-03-17
08592346893436VarimedVM N2O CGA326 _ _ 9/16 S0729118US2025-03-17
08592346918276VarimedVM O2 CGA540 _ PTBH 9/16 G0729120US2025-03-17
08592346944831Varimed+VM+ N2O PI DS _ _ S0729125US2025-03-17
08592346944848VarimedVM N2O CGA326 DS _ _ S0729126US2025-03-17
08592346946033Varimed+VM+ CO2 CGA320 DS _ _ S0729127US2025-03-17
08592346946040VarimedVM CO2 CGA320 DS _ _ S0729128US2025-03-17
08592346935426Varimed+VM+ CO2 PI DS _ _ S0729123US2024-10-23
08592346935440Varimed+VM+ N2O CGA326 DS _ _ S0729124US2024-10-23
08592346935464Varimed+VM+ AIR PI DS _ _ S0729121US2024-10-23
08592346935471Varimed+VM+ AIR CGA346 DS _ _ S0729122US2024-10-23
08592346898165MediVitopMT25 O2 3/4UNF CGA540R DS S0712601US2024-06-13
08592346893443MR AIR_PI_DS _ _ G0724109US2023-12-12
08592346893450VM AIR PI _ _ 9/16 G0729119US2023-12-12
08592346892583MS25 O2 PI DS _ 9/16 S0720121US2023-12-04

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