FDA.reportPublic FDA data

Eclipse Oxygen Concentrator

Primary DI
M7665900SEQ0
Brand
Eclipse Oxygen Concentrator
Company
CAIRE INC.
Model
5900-SEQ
Device description
Eclipse 3 Portable Oxygen Concentrator 0.5-3 LPM, Continuous and Pulse Dose Settings
Published
2015-07-01
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
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013931000OMNI OXYGEN SYSTEM, MODEL 1000Sequal Technologies, Inc.2002-03-27CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7665900SEQ0PrimaryHIBCC0

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
00822383027180DECO, 5L Oxygen ConcentratorDrive Devilbiss HealthcareCAW2026-10-29
00822383035482SIMO2, Portable Oxygen ConcentratorDrive Devilbiss HealthcareCAW2026-10-29
00822383036885SIMO2, Portable Oxygen Concentrator, Extended BatteryDrive Devilbiss HealthcareCAW2026-10-29
06973632410070OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06973632410100OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06973632410124OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06973632410155OXTMOxytek Medical Technology Co., Ltd.CAW2026-10-15
06970384252163SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360078HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360085HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
06975247360092HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-30
16970384252160SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
26970384252167SCIANHONSUN (NANTONG) CO.,LTDCAW2026-07-30
06975247360061HarveyMedShenzhen HarveyMed Technology Co., Ltd.CAW2026-07-27
00841447114635Invacare® Platinum Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
06977388230012WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230029WeOxyWeoxy Co., LTD.CAW2025-09-25
06977388230036WeOxyWeoxy Co., LTD.CAW2025-09-25
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00860012953301MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28