FDA.reportPublic FDA data

STROLLER

Primary DI
M766109980030
Brand
STROLLER
Company
CAIRE INC.
Model
10998003
Device description
Portable Liquid Oxygen Respiratory Equipment, Top Fill, 6 LPM, 20 PSI
Published
2016-08-17
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
K800742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800742000LIBERATOR/STROLLER II SYSTEMCryogenic Assoc.1980-05-23BYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M766109980030PrimaryHIBCC0

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