FDA.reportPublic FDA data

Invacare® HomeFill® Oxygen System

Primary DI
00841447100195
Brand
Invacare® HomeFill® Oxygen System
Company
INVACARE CORPORATION
Model
IOH200C
Catalog number
IOH200C
Published
2015-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K003939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003939000VENTURE HOME FILL II, MODEL IOH 200Invacare Corp.2001-03-21CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841447100195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841447100195008414471001958414471001950841447100195

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen compressor, home-useA mains electricity (AC-powered) electromechanical device intended to be used in conjunction with a stationary oxygen concentrator to pressurize and fill/refill ambulatory oxygen cylinders with medical oxygen (O2). It is operated by the patient in the home to facilitate mobile oxygen therapy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Fahrenheit150 Degrees Fahrenheit
Storage Environment Temperature-20 Degrees Fahrenheit150 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-329-6000orders@invacare.com

Regulatory Flags#

DUNS number
076916246
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841447197966INVACARE® DLX SERIES BED RAILIH6803AIH6803A2026-09-22
00841447198048INVACARE® THINKSOFT® POSITIONING DEVICEIHCSTSPDIHCSTSPD2026-09-22
00841447198086Invacare® AspiratorIRC1135IRC11352026-09-22
00841447198093Invacare® Element™ Pneumatic ConserverIOC100PIOC100P2026-09-22
00841447199953INVACARE® BAR600 BARIATRIC BEDBAR600IVCBAR600IVC2026-09-21
00841447198116INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR18BM61PSR18B2026-09-20
00841447198123INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR18RM61PSR18R2026-09-20
00841447198130INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR20RM61PSR20R2026-09-20
00841447198147INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR20BM61PSR20B2026-09-20
00841447198154INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61RM61R2026-09-20
00841447198161INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61M612026-09-20
00841447198178INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR16BM61PSR16B2026-09-20
00841447198185INVACARE® PRONTO® M61™ POWER WHEELCHAIRM61PSR16RM61PSR16R2026-09-20
00841447198192INVACARE® PRONTO® M61™ POWER WHEELCHAIRATO_M61ATO_M612026-09-20
00841447198208INVACARE® PRONTO® M61™ POWER WHEELCHAIRATO_M61RATO_M61R2026-09-20
00841447198215INVACARE® PRONTO® 31 POWER WHEELCHAIRP31BLUEP31BLUE2026-09-20
00841447198222INVACARE® PRONTO® 31 POWER WHEELCHAIRP31BLACKP31BLACK2026-09-20
00841447198239INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGAIRPTMBDY18AIRPTMBDY182026-09-20
00841447198246INVACARE® PRONTO® AIR PERSONAL TRANSPORTER W/ MYBODY® SEATINGAIRPTMBDY20AIRPTMBDY202026-09-20
00841447198253INVACARE® PRONTO® M91™ POWER WHEELCHAIRATO_M91-TSATO_M91-TS2026-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
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M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00860012953301MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28
00860012953318MICITECHFoshan MIC Medical Technology Co.,Ltd.CAW2024-11-28