FDA.reportPublic FDA data

Spirit Portable Liquid Oxygen

Primary DI
M766138327460
Brand
Spirit Portable Liquid Oxygen
Company
CAIRE INC.
Model
13832746
Device description
Portable Liquid Oxygen Respiratory Equipment, 300, Top Fill, 20 PSI
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYJUnit, Liquid-Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYJUnit, Liquid-Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080023000MODIFICATION TO: SPIRITCaire, Inc.2008-06-16BYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M766138327460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Portable liquid oxygen unitAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
807537683
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M766AS200SW460AryaAS200-SW462025-08-13
M766AS2001410CAIRE Inc.AS200-141AS200-1412025-08-13
M766AS2001460AryaAS200-1462025-08-13
M766AS2002410CAIRE Inc.AS200-241AS200-2412025-08-13
M766AS2002460AryaAS200-2462025-08-13
M766AS200410CAIRE Inc.AS200-41AS200-412025-08-13
M766AS200460AryaAS200-46AS200-SW412025-08-13
M766AS200SW410CAIRE Inc.AS200-SW41AS200-SW412025-08-13
M766SCE1000NANB0HOMESTYLE AspenSCE1000-NANBSCE1000-NANB2025-06-30
M766214997340IntenOxy 521499734214997342024-11-13
M766AS2006R0AryaAS200-6RAS200-6R2024-11-13
M766AS2001R0FreeStyle ComfortAS200-1RAS200-1R2024-08-09
M766AS200SW6AryaAS200-SW62022-05-26
M766AS2001060AryaAS200-1062021-11-08
M766AS2002060AryaAS200-2062021-11-08
M766AS20060AryaAS200-62021-11-08
M766AS200SW30FreeStyle Comfort AS200-SW32020-08-06
M76613256929SM0Liberator13256929SM2020-08-06
M76613256961SM0Liberator13256961SM2020-08-06
M76613256996SM0Liberator13256996SM2020-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10815363020049Backpack Medical Oxygen System, BMOSESSEX INDUSTRIES, INC.BYJ2026-03-02
10815363020056Backpack Medical Oxygen System, BMOSESSEX INDUSTRIES, INC.BYJ2026-03-02
10815363020070Mounted Medical Oxygen System, MMOSESSEX INDUSTRIES, INC.BYJ2026-03-02
M76613256929SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613256961SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613256996SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613258385SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613258406SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613258449SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613258537SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613258641SM0Liberator CAIRE INC.BYJ2020-08-06
M76613259468SM0LiberatorCAIRE INC.BYJ2020-08-06
M76613548243SM0LiberatorCAIRE INC.BYJ2020-08-06
M76614168314SM0LiberatorCAIRE INC.BYJ2020-08-06
M76614454960SM0LiberatorCAIRE INC.BYJ2020-08-06
M76614454978SM0LiberatorCAIRE INC.BYJ2020-08-06
M76615090379SM0LiberatorCAIRE INC.BYJ2020-08-06
M76620606186SM0LiberatorCAIRE INC.BYJ2020-08-06
M766118549840EMSCAIRE INC.BYJ2016-08-29
M766132544640LiberatorCAIRE INC.BYJ2016-08-29
M766132545520LiberatorCAIRE INC.BYJ2016-08-29
M766132545790LiberatorCAIRE INC.BYJ2016-08-29
M766132561100LiberatorCAIRE INC.BYJ2016-08-29
M766132561950LiberatorCAIRE INC.BYJ2016-08-29
M766132563800LiberatorCAIRE INC.BYJ2016-08-29
M766132564350LiberatorCAIRE INC.BYJ2016-08-29
M766132565820LiberatorCAIRE INC.BYJ2016-08-29
M766132565910LiberatorCAIRE INC.BYJ2016-08-29
M766132566540LiberatorCAIRE INC.BYJ2016-08-29
M766132568060LiberatorCAIRE INC.BYJ2016-08-29