DEVICE: Spirit Portable Liquid Oxygen (M766131042040)

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Device Identifier (DI) Information
Spirit Portable Liquid Oxygen
13104204
In Commercial Distribution

CAIRE INC.
M766131042040
HIBCC

1
807537683 *Terms of Use
Portable Liquid Oxygen Respiratory Equipment, Top Fill, 5 LPM, 20 PSI
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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GMDN

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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?
35910 Portable liquid oxygen unit
An empty device designed as a portable, supplemental, refillable container intended as a storage for liquid oxygen (LOX) and its conversion into gaseous form for delivery of medical oxygen (O2) at various pulsed or fixed flow settings to a patient who typically has difficulty extracting O2 from the atmosphere. It typically consists of a cryogenic canister containing the LOX, a mechanism (e.g., a warming coil) where the LOX is converted into gas, a gas delivery control device (e.g., demand valve or fixed flow mechanism) that regulates the flow of O2 to the patient, a fill port and an outlet connection for connection of a nasal cannula or face mask.
Active false
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FDA Product Code

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Product Code Product Code Name
BYJ Unit, Liquid-Oxygen, Portable
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K080023 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
7c683d79-8a0c-431d-9ea5-253517822ce3
October 23, 2019
4
August 18, 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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Yes
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Customer Contact

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No Customer Contact currently defined
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