FDA.reportPublic FDA data

Varimed

Primary DI
08592346893429
Brand
Varimed
Company
GCE, s.r.o.
Model
0729117US
Catalog number
VM AIR CGA346 _ _ DS S
Device description
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
Published
2025-03-17
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
08592346893429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346893429085923468934298592346893429

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
false
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
08592346652187Amvex FlowmeterFA-03IO-F2FLOWMETER 0-3 L/MIN ISO OXY 1/8" FNPT2026-07-07
08592346652194Amvex FlowmeterFA-03IO-DNFLOWMETER 0-3 L/MIN ISO OXY DISS NUT2026-07-07
08592346652200Amvex FlowmeterFA-03UO-F2FLOWMETER 0-3 L/MIN USA OXY 1/8" FNPT2026-07-07
08592346652217Amvex FlowmeterFA-03UO-DNFLOWMETER 0-3 L/MIN USA OXY DISS NUT2026-07-07
08592346652224Amvex FlowmeterFA-15IO-F2FLOWMETER 0-15 L/MIN ISO OXY 1/8" FNPT2026-07-07
08592346692329Amvex FlowmeterFA-15IO-DNFLOWMETER 0-15 L/MIN ISO OXY DISS NUT2026-07-07
08592346692404Amvex FlowmeterFA-15UO-F2FLOWMETER 0-15 L/MIN USA OXY 1/8" FNPT2026-07-07
08592346692442Amvex FlowmeterFA-15UO-DNFLOWMETER 0-15 L/MIN USA OXY DISS NUT2026-07-07
08592346692466Amvex FlowmeterFA-15IO-F2PTFLOWMETER 0-15 L/MIN ISO OXY 1/8" FNPT PTO2026-07-07
08592346692503Amvex FlowmeterFA-15IO-DNPTFLOWMETER 0-15 L/MIN ISO OXY DISS NUT PTO2026-07-07
08592346696914Amvex FlowmeterFA-15UO-F2PTFLOWMETER 0-15 L/MIN USA OXY 1/8" FNPT PTO2026-07-07
08592346705302Amvex FlowmeterFA-15UO-DNPTFLOWMETER 0-15 L/MIN USA OXY DISS NUT PTO2026-07-07
08592346732926Amvex FlowmeterFA-15IA-F2FLOWMETER 0-15 L/MIN ISO AIR 1/8" FNPT2026-07-07
08592346782013Amvex FlowmeterFA-15IA-DNFLOWMETER 0-15 L/MIN ISO AIR DISS NUT2026-07-07
08592346782020Amvex FlowmeterFA-15UA-F2FLOWMETER 0-15 L/MIN USA AIR 1/8" FNPT2026-07-07
08592346782075Amvex FlowmeterFA-15UA-DNFLOWMETER 0-15 L/MIN USA AIR DISS NUT2026-07-07
08592346782655Amvex FlowmeterFA-15IA-F2PTFLOWMETER 0-15 L/MIN ISO AIR 1/8" FNPT PTO2026-07-07
08592346782723Amvex FlowmeterFA-15IA-CHPTFLOWMETER 0-15 L/MIN ISO AIR CHEM PTO2026-07-07
08592346782730Amvex FlowmeterFA-15IA-DNPTFLOWMETER 0-15 L/MIN ISO AIR DISS NUT PTO2026-07-07
08592346815858Amvex FlowmeterFA-15IA-DHPTFLOWMETER 0-15 L/MIN ISO AIR DISS HT PTO2026-07-07

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
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
G298153187220010NAControl Devices, LLCCAN2024-07-26