FDA.reportPublic FDA data

MediReg II

Primary DI
08592346786585
Brand
MediReg II
Company
GCE, s.r.o.
Model
MR15F O2 CGA540_ _ 9/16 G
Catalog number
0724104US
Device description
The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets.
Published
2023-02-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

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
08592346786585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346786585085923467865858592346786585

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 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 table
Method

Regulatory Flags#

DUNS number
819753190
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
00848530109455Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2026-07-23
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00848530108168RegulatorsSunset Healthcare Solutions, Inc.CAN2026-02-02
00848530108120RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530108151RegulatorSunset Healthcare Solutions, Inc.CAN2026-01-26
00848530107765Repair PartsSunset Healthcare Solutions, Inc.CAN2025-11-24
00848530107413React Regulator ValveSunset Healthcare Solutions, Inc.CAN2025-09-17
00848530106034Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
00848530106041Oxygen AccessorySunset Healthcare Solutions, Inc.CAN2025-06-03
08592346893429VarimedGCE, s.r.o.CAN2025-03-17
08592346893436VarimedGCE, s.r.o.CAN2025-03-17
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
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