DEVICE: Lifogen (00260720011018)

Device Identifier (DI) Information

Lifogen
0022-230P
In Commercial Distribution
31-01-0600
ALLIED HEALTHCARE PRODUCTS, INC.
00260720011018
GS1

1
099674145 *Terms of Use
Emergency Oxygen Unit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
Yes
No

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 [?]
K895956 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a1209da7-cf45-4e7c-8e67-e8d148d80318
July 06, 2018
3
September 20, 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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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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