DEVICE: LIFE®SoftPac (B188LIFE26FF0)
Device Identifier (DI) Information
LIFE®SoftPac
LIFE-2-6FF
In Commercial Distribution
LIFE CORPORATION
LIFE-2-6FF
In Commercial Distribution
LIFE CORPORATION
LIFE®SoftPac Emergency Oxygen Unit is lightweight (6 lbs) for easy portability and frequent carrying. A fixed-flow regulator provides a 40 minute supply of oxygen at 6LPM.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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31760 | Fixed-regulator oxygen refillable cylinder |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CAN | Regulator, Pressure, Gas Cylinder |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 125 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 255 Liter |
Device Record Status
dc18bb40-b47f-444b-9108-97ae9b9c59a0
March 10, 2021
3
June 29, 2016
March 10, 2021
3
June 29, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-700-0202
Email@LIFEcorporation.com
Email@LIFEcorporation.com