FDA.reportPublic FDA data

InnoSpire Deluxe

Primary DI
06946159502023
Brand
InnoSpire Deluxe
Company
VEGA TECHNOLOGIES INC.
Model
1112279
Device description
1112279
Published
2018-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031413000VIGORMIST COMPRESSOR NEBULIZERVega Technologies, Inc.2003-10-07BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16946159502020PackageGS16In Commercial Distribution
06946159502023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694615950202016946159502020
06946159502023069461595020236946159502023

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Regulatory Flags#

DUNS number
421290561
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06946159503488VEGACM-012024-05-13
06946159501484VEGACM-012023-09-01
06946159501026Sami the Seal10932702018-06-01
06946159501033Sami the Seal10932372018-06-01
06946159501040Sami the Seal10932682018-06-01
06946159501057Sami the Seal10824562018-06-01
06946159501064Sami the Seal10827312018-06-01
06946159501071Sami the Seal11143732018-06-01
06946159501088Sami the Seal11194622018-06-01
06946159501095Sami the Seal11369552018-06-01
06946159502016InnoSpire Deluxe11122782018-06-01
06946159502030Innospire Deluxe11100622018-06-01
06946159502047Innospire Deluxe11100632018-06-01
06946159502054Innospire Deluxe11100662018-06-01
06946159502061Innospire Deluxe11100642018-06-01
06946159502078Innospire Deluxe11100592018-06-01
06946159502085Innospire Deluxe11100572018-06-01
06946159502092Innospire Deluxe11100582018-06-01
06946159502108Innospire Deluxe11100602018-06-01
06946159502115Innospire Deluxe11100612018-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344214723MEDLINEMEDLINE INDUSTRIES, INC.BTI2026-07-13
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
00848530087524Power and AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087531Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099893Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099923Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087517Nebulizer Medicine CupSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099107Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087500Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093884Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095062Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095079Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530089818Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093853Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530098216Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100377Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100384Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100391Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100407Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30