FDA.reportPublic FDA data

Inogen At Home Stationary Concentrator

Primary DI
00817131020148
Brand
Inogen At Home Stationary Concentrator
Company
Inogen, Inc.
Model
CE
Catalog number
GS-100
Device description
Inogen At Home Stationary Concentrator, CE (10-06316-XX-XX)
Published
2017-03-27
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
K132489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132489000INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)Inogen, Inc.2014-06-20CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817131020148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817131020148008171310201488171310201480817131020148

GMDN Terms#

Term, Definition table
TermDefinition
Stationary oxygen concentratorA stationary 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 typically wheeled but is designed to be placed in one location, e.g., an institution or a home setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-13 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
805-562-0500compliance@inogen.net

Regulatory Flags#

DUNS number
136729634
Device count
1
Serial number
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

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