FDA.reportPublic FDA data

LIFE®Regulator

Primary DI
B188LIFE612REG0
Brand
LIFE®Regulator
Company
Mv Life LLC
Model
LIFE-612 Regulator
Device description
Oxygen regulator providing variable 6 & 12 LPM flow-rates. For use with LIFE® Emergency Oxygen Units.
Published
2016-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
B188LIFE612REG0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen 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 an oxygen (O2) cylinder to lower high, variable gas pressure (e.g., 50 - 250 bar) to a lower, constant working pressure, typically 3 - 5 bar. 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, usually a manometer or manometers, to display the available gas reserve of a gas cylinder and the working pressure.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-700-0202Email@LIFEcorporation.com

Regulatory Flags#

DUNS number
096584064
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B188LIFE0250LIFE®OxygenPacLIFE-0252016-06-29
B188LIFE025REG0LIFE®RegulatorLIFE-025 Regulator2016-06-29
B188LIFE1000LIFE®CPR MaskLIFE-1002016-06-29
B188LIFE100B0LIFE®CPR MaskLIFE-100-B2016-06-29
B188LIFE1010LIFE®CylinderLIFE-1012016-06-29
B188LIFE1020LIFE®CPR MaskLIFE-1022016-06-29
B188LIFE20250LIFE®SoftPacLIFE-2-0252016-06-29
B188LIFE21010LIFE®CylinderLIFE-2-1012016-06-29
B188LIFE26120LIFE®SoftPacLIFE-2-6122016-06-29
B188LIFE26FF0LIFE®SoftPacLIFE-2-6FF2016-06-29
B188LIFE6120LIFE®OxygenPacLIFE-6122016-06-29
B188LIFE6FF0LIFE®OxygenPacLIFE-6FF2016-06-29
B188LIFE6FFREG0LIFE®RegulatorLIFE-6FF Regulator2016-06-29
B188LIFEEMS02510LIFE®RegulatorLIFE-EMS-025-12016-06-29
B188LIFEEMS02530LIFE®RegulatorLIFE-EMS-025-32016-06-29
B188LIFEEMSD0LIFE®CylinderLIFE-EMS-D2016-06-29
B188LIFEEMSE0LIFE®CylinderLIFE-EMS-E2016-06-29
B188LIFEO21010LIFE®CylinderLIFE-O2-1012016-06-29
B188LIFEO2LSS0LIFE®StartSystemLIFE-O2-LSS2016-06-29
00860009971103OxyHome1400-51002023-03-28

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