FDA.reportPublic FDA data

HomeFill® Oxygen System

Primary DI
00850018761307
Brand
HomeFill® Oxygen System
Company
Ventec Life Systems, Inc.
Model
IOH200
Catalog number
IOH200
Published
2023-10-16
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
CAWGenerator, Oxygen, Portable

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021685000VENTURE HOMEFILL II WITH OXYGEN CONSERVERInvacare Corp.2002-07-23CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018761307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018761307008500187613078500187613070850018761307

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
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Fahrenheit150 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078758082
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018761048VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-00X2020-10-07
00850018761062VOCSN Patient Breathing PackageAdult, Active, Heated, Oxygen, BluePRT-00798-00X2020-10-07
00850018761116VOCSNV+C, JapanesePRT-01098-1XX2021-02-23
00855573007013VOCSN External Bacterial FilterPRT-00790-001PRT-00790-0032017-11-11
00855573007037VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-0012017-11-11
00855573007044VOCSN Patient Breathing PackageAdult, Passive, Oxygen, BluePRT-00793-0012017-11-11
00855573007075VOCSN Patient Breathing PackageAdult, Passive, BluePRT-00792-0012019-01-30
00855573007082VOCSN Patient Breathing PackageAdult, Active, Heated, BluePRT-00795-0012019-01-30
00855573007099VOCSN Patient Breathing Package Adult, Passive, Heated, BluePRT-00796-0012019-01-30
00855573007105VOCSN Nurse Call CableNormally ClosedPRT-00820-0012017-11-11
00855573007112VOCSN Nurse Call CableNormally OpenPRT-00821-0012017-11-11
00855573007129VOCSN Travel Suction CanisterPRT-00824-000PRT-00824-0012017-11-11
00855573007181VOCSN Patient Breathing PackagePediatric, Valveless, BluePRT-00927-0012019-01-30
00855573007228VOCSN Patient Breathing PackageAdult, Valveless, BluePRT-00926-0012019-01-30
00855573007235VOCSN Patient Breathing PackageAdult, Valveless, Heated, BluePRT-00928-0012019-01-30
00855573007341VOCSN Patient Breathing PackagePediatric, Valveless, Heated, BluePRT-00929-0012019-01-30
00855573007549VOCSN Patient Breathing PackagePediatric, Active, BluePRT-00799-0012018-07-10
00855573007563VOCSN Patient Breathing PackagePediatric, Active, Heated, BluePRT-00803-0012018-07-11
00855573007587VOCSN Patient Breathing PackagePediatric, Active, Oxygen, BluePRT-00802-0012018-07-11
00855573007600VOCSN Patient Breathing PackagePediatric, Active, Heated, Oxygen, BluePRT-00806-0012018-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00885304034834DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034841DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034858DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
06934726614316LongfianLongfian Scitech Co., Ltd.CAW2026-05-04
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
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00855573007761VOCSNVentec Life Systems, Inc.CAW2022-04-12
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03
00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07