FDA.reportPublic FDA data

Varimed

Primary DI
08592346755505
Brand
Varimed
Company
GCE, s.r.o.
Model
0729104US
Catalog number
VM AIR CGA346 _ _ DS G
Device description
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
Published
2021-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592346755505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346755505085923467555058592346755505

GMDN Terms#

Term, Definition table
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 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.

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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592346893429Varimed0729117USVM AIR CGA346 _ _ DS S2025-03-17
08592346893436Varimed0729118USVM N2O CGA326 _ _ DS S2025-03-17
08592346893450Varimed0729119USVM AIR CGA950 _ _ DS G2023-12-12
08592346828063Varimed0729110USVM AIR CGA346 _ _ DS S2022-07-13
08592346828070Varimed0729111USVM N2O CGA326 _ _ DS S2022-07-13
08592346779709Varimed0729105USVM N2O CGA326 _ _ DS G2022-07-12
08592346748033MediFlowTec0726501USMFT 25 _ O2 DS _9/16 G2021-02-17
08592346749375MediFlowTec0726502USMFT 25 _ AIR DS _ 9/16 G2021-02-17
08592346849563MediMeter0730113USMM30 _O2 DS _ 9/16UNF S2022-10-03
08592346849570MediMeter0730114USMM60 _O2 DS _ 9/16UNF S2022-10-03
08592346820975MediConnect0731020USMCN AIR Y2 DSF DS S2022-07-21
08592346820982MediConnect0731021USMCN VAC W1 DSF DSF S2022-07-21
08592346820999MediConnect0731022USMCN VAC W1 DSF DS S2022-07-21
08592346821002MediConnect0731023USMCN VAC W2 DSF DSF S2022-07-21
08592346821019MediConnect0731024USMCN VAC W2 DSF DS S2022-07-21
08592346756434MediConnect0731007USMCN AIR Y2 DSF DSF G2022-07-20
08592346756441MediConnect0731005USMCN AIR Y1 DSF DSF G2022-07-20
08592346756793MediConnect0731004USMCN O2 G2 DSF DS G2022-07-20
08592346756809MediConnect0731006USMCN AIR Y1 DSF DS G2022-07-20
08592346756816MediConnect0731008USMCN AIR Y2 DSF DS G2022-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00819601025837EscalonAirgas Therapeutics, LLCCAN2025-11-21
08592346893429VarimedGCE, s.r.o.CAN2025-03-17
08592346893436VarimedGCE, s.r.o.CAN2025-03-17
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
G298153187270020NAControl Devices, LLCCAN2024-08-08
G298153187270040NAControl Devices, LLCCAN2024-08-08
G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
G298153187280010NAControl Devices, LLCCAN2024-08-08
G298153187280020NAControl Devices, LLCCAN2024-08-08
G298153187280030NAControl Devices, LLCCAN2024-08-08
G298153187280040NAControl Devices, LLCCAN2024-08-08
G2982108080NAControl Devices, LLCCAN2024-08-08
G2982108150NAControl Devices, LLCCAN2024-08-08
G2982108250NAControl Devices, LLCCAN2024-08-08
G2982212200NAControl Devices, LLCCAN2024-08-08
G2982216200NAControl Devices, LLCCAN2024-08-08
G2982217200NAControl Devices, LLCCAN2024-08-08
G298153187280050NAControl Devices, LLCCAN2024-07-30
G298153187280080NAControl Devices, LLCCAN2024-07-30
G298202230NAControl Devices, LLCCAN2024-07-30