FDA.reportPublic FDA data

Inogen Tidal Assist Ventilator Controller

Primary DI
00817131020216
Brand
Inogen Tidal Assist Ventilator Controller
Company
Inogen, Inc.
Model
VC-100
Catalog number
VC-100
Device description
Inogen Tidal Assist Ventilator Controller
Published
2020-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ONZMechanical Ventilator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONZMechanical VentilatorAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152664000TAV SystemNew Aera, Inc.2016-12-02ONZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817131020216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817131020216008171310202168171310202160817131020216

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
136729634
Device count
1
DM exempt
true
Kit
true
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
008171310202541240 O2 DISS Regulator TAV 10-09779-XX-012020-03-13
008171310202611160 AIR DISS Regulator TAV 10-09841-XX-012020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081713102039125ft O2 Delivery Tube TAV, 1PKInogen, Inc.ONZ2020-03-20
0081713102040750ft O2 Delivery Tube TAV, 1PKInogen, Inc.ONZ2020-03-20
00817131020223TAV 7ft O2 Delivery Tubing Inogen, Inc.ONZ2020-03-20
00817131020230TAV 25ft O2 Delivery Tubing Inogen, Inc.ONZ2020-03-20
00817131020247TAV 50ft O2 Delivery Tubing Inogen, Inc.ONZ2020-03-20
00817131020308TAV Nasal Interface Inogen, Inc.ONZ2020-03-20
00817131020377Nasal Interface, 1PKInogen, Inc.ONZ2020-03-20
008171310203847ft O2 Delivery Tube TAV, 1PKInogen, Inc.ONZ2020-03-20
0081713102033925ft O2 Delivery Tube TAV, 1PKINOGEN, INC.ONZ2020-03-20
0081713102034650ft O2 Delivery Tube TAV, 1PKINOGEN, INC.ONZ2020-03-20
00817131020209Inogen Tidal Assist Ventilator SystemInogen, Inc.ONZ2020-03-13
008171310202541240 O2 DISS Regulator TAV Inogen, Inc.ONZ2020-03-13
008171310202611160 AIR DISS Regulator TAV Inogen, Inc.ONZ2020-03-13
00817131020315Nasal Interface, 3Pk Inogen, Inc.ONZ2020-03-13
00852682007361Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.ONZ2017-06-30
00899660002383Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.ONZ2016-12-12
00852682007002Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.ONZ2016-12-12
00852682007019Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.ONZ2016-12-12
00852682007026Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.ONZ2016-12-12
00852682007156Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.ONZ2016-12-12