FDA.reportPublic FDA data

TAV Nasal Interface

Primary DI
00817131020308
Brand
TAV Nasal Interface
Company
Inogen, Inc.
Model
10-09815-XX-01
Device description
TAV Nasal Interface (10-09815-XX-01)
Published
2020-03-20
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
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
00817131020308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817131020308008171310203088171310203080817131020308

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

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
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
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
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
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
00817131020216Inogen Tidal Assist Ventilator Controller Inogen, 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