DEVICE: LIFE®SoftPac (B188LIFE26FF0)

Device Identifier (DI) Information

LIFE®SoftPac
LIFE-2-6FF
In Commercial Distribution

LIFE CORPORATION
B188LIFE26FF0
HIBCC

1
151860053 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Fixed-regulator oxygen 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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FDA Product Code

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Product Code Product Code Name
CAN Regulator, Pressure, Gas Cylinder
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 125 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Total Volume: 255 Liter
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Device Record Status

dc18bb40-b47f-444b-9108-97ae9b9c59a0
March 29, 2018
2
June 29, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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No CLOSE

Customer Contact

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1-800-700-0202
Email@LIFEcorporation.com
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