FDA.reportPublic FDA data

Inogen One G4 Oxygen Concentrator - Bluetooth

Primary DI
00817131020179
Brand
Inogen One G4 Oxygen Concentrator - Bluetooth
Company
Inogen, Inc.
Model
630 Bluetooth
Catalog number
IO-400
Device description
Inogen One G4 Oxygen Concentrator - Bluetooth (10-08300-00-01)
Published
2019-01-07
Public version status
Update
Distribution status
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
K032818000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032818000INOGEN ONE OXYGEN CONCENTRATORInogen, Inc.2004-05-13CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817131020179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817131020179008171310201798171310201790817131020179

GMDN Terms#

Term, Definition table
TermDefinition
Portable oxygen concentratorA portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8055620500compliance@inogen.net

Regulatory Flags#

DUNS number
136729634
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
36642240000232TUB10TUB10TUB-102025-03-12
36642240000928SIMEOX 200SIMEOX-2 BACD-200B2025-03-12
36642240001604SIMEOXSIMEOXSIMEOX_H2025-03-12
36642240001772TUB25TUB-25CON-25012025-03-12
36642240001840SIMEOX 200SIMEOX-2ACD-2002025-03-12
00817131020698OxyGo Fit+ Rove 4 OxyGo Fit+ (10-13401-00-01)2025-06-12
00817131020704Oxygo Next Rove 6 OxyGo Next Rove 6 (10-13402-00-01)2025-06-11
0081713102039125ft O2 Delivery Tube TAV, 1PKRP-1011RP-10112020-03-20
0081713102040750ft O2 Delivery Tube TAV, 1PKRP-1012RP-10122020-03-20
00817131020414Inogen Rove 410-10417-00-01 (BT)IO-4012024-10-24
00817131020513Inogen Rove 610-12017-00-02 (BT)IO-5012024-10-24
00817131020223TAV 7ft O2 Delivery Tubing 10-09889-XX-012020-03-20
00817131020230TAV 25ft O2 Delivery Tubing 10-09890-XX-012020-03-20
00817131020247TAV 50ft O2 Delivery Tubing 10-09891-XX-012020-03-20
00817131020308TAV Nasal Interface 10-09815-XX-012020-03-20
00817131020377Nasal Interface, 1PKRP-1009RP-10092020-03-20
008171310203847ft O2 Delivery Tube TAV, 1PKRP-1010RP-10102020-03-20
00817131020209Inogen Tidal Assist Ventilator SystemVS-100VS-1002020-03-13
00817131020216Inogen Tidal Assist Ventilator Controller VC-100VC-1002020-03-13
008171310202541240 O2 DISS Regulator TAV 10-09779-XX-012020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06953077101160Oxygen concentratorShenyang Canta Medical Tech.Co.,LtdCAW2025-10-08
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