FDA.reportPublic FDA data

LIFE®SoftPac

Primary DI
B188LIFE26120
Brand
LIFE®SoftPac
Company
Mv Life LLC
Model
LIFE-2-612
Device description
LIFE®SoftPac Emergency Oxygen Unit is lightweight (6 lbs) for easy portability and frequent carrying. A 6&12 LPM (NORM & HIGH), variable-flow regulator provides a 40 minute supply of oxygen at 6LPM.
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
B188LIFE26120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fixed-regulator oxygen cylinderA container designed as a refillable cylinder with an integrated pressure regulator used to hold compressed medical oxygen (O2) under safe conditions at high pressure (e.g., 50 - 200 Bar). It is typically filled with O2 when delivered from the gas supplier and includes a built-in pressure regulator that, when activated, releases the O2 at the correct working pressure. It is available in some cylinder sizes (capacity) and colour-coded to denote O2 content. The cylinder may be made of steel, aluminium (Al) or other ferrous or non-ferrous materials. O2 is used as an essential life support gas, for anaesthesia, and for therapeutic purposes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume255Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit125 Degrees Fahrenheit

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
Combination product
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
B188LIFE26FF0LIFE®SoftPacLIFE-2-6FF2016-06-29
B188LIFE6120LIFE®OxygenPacLIFE-6122016-06-29
B188LIFE612REG0LIFE®RegulatorLIFE-612 Regulator2016-06-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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