FDA.reportPublic FDA data

QualityREG

Primary DI
04251411705893
Brand
QualityREG
Company
DEHAS Medical Systems GmbH
Model
DM-ISO-MS-NIST-CO2
Catalog number
DM-ISO-MS-NIST-CO2
Device description
QualityREG CO2 Pressure Regulator, Connection ISO 5145, NIST incl. Pressure gauge
Published
2024-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
04251411705893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251411705893042514117058934251411705893

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Minus 20° Celsius to +60° Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343728657
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
04251411706029QualityREGDM-AD-CO2-NIST-DIN-KDM-AD-CO2-NIST-DIN-K2024-07-24
04251411703691Quality Connect HDUI024HD-CO2-716-W21-0,552023-01-02
04251411703714Quality Connect HDUI025HD-CO2-716-W21-1,022023-01-02
04251411703721Quality Connect HDUI026HD-CO2-716-PIN-0,552023-01-02
04251411703745Quality Connect HDUI027HD-CO2-716-PIN-1,022023-01-02
04251411703769Quality Connect HDUI028HD-CO2-716-ISO-1,022023-01-02
04251411703776Quality ConnectUI021DIN-CO2-ZGV-716-1,502023-01-02
04251411703783Quality ConnectUI022DIN-CO2-ZGV-716-3,002023-01-02
04251411703790Quality ConnectUI020DISS-CO2-ZGV-716-1,502023-01-02
04251411703806Quality ConnectUI023DIN-CO2-ZGV-716-6,002023-01-02
04251411701833Quality Connect DIN-CO2-NIST-NIST-1,5DIN-CO2-NIST-NIST1,52024-04-16
04251411701840Quality ConnectDIN-CO2-ZGV-NIST-1,5DIN-CO2-ZGVNIST1,52024-04-16
04251411703141Quality ConnectNF-CO2-ZGV-NIST-5,0NF-CO2-ZGV-NIST5,02024-04-16
04251411707200Quality ConnectRW-CO2-ZGV-NIST-5,0RW-CO2-ZGV-NIST-5,02024-04-16
04251411705879QualityREGDM-DIN6-MS-NIST-CO22024-04-08
04251411705886QualityREGDM-PIN-MS-NIST-CO2DM-PIN-MS-NIST-CO22024-04-08
04251411700010Oxymixer High Flow SETHigh Flow SETMP042012023-02-17
04251411700027Oxymixer Low Flow SETLow Flow SETMP042032023-02-17
04251411700775Oxymixer XL Low FlowXL Low Flow2023-02-17
04251411700928Oxymixer Low Flow 15LPMLow Flow 15LPMMP042292023-02-17

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