FDA.reportPublic FDA data

LITEAIRE

Primary DI
00383480000495
Brand
LITEAIRE
Company
THAYER MEDICAL CORPORATION
Model
1303
Catalog number
1303, 1304, 1306
Device description
DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER: CATALOG NUMBER 1303 IS 1 INDIVIDUAL LITEAIRE UNIT. CATALOG NUMBER 1304 IS 1 DISPENSER BOX CONTAINING 25 INDIVIDUAL LITEAIRE UNITS IN A SHIPPING CONTAINER. CATALOG NUMBER 1306 IS 4 DISPENSER BOXES, EACH CONTAINING 25 LITEAIRE UNITS (100 LITEAIRE UNITS IN TOTAL) IN A SHIPPING CONTAINER.
Published
2016-09-21
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
CAFNebulizer (Direct Patient Interface)
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2
NVPHolding Chambers, Direct Patient InterfaceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383480000492PackageGS125In Commercial Distribution
20383480000499PackageGS11In Commercial Distribution
30383480000496PackageGS14In Commercial Distribution
40383480000493PackageGS125In Commercial Distribution
00383480000495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038348000049210383480000492
2038348000049920383480000499
3038348000049630383480000496
4038348000049340383480000493
00383480000495003834800004953834800004950383480000495

GMDN Terms#

Term, Definition table
TermDefinition
Medicine chamber spacer, reusableA device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic materials and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise deposit in the mouth/upper airway, but are intended for the lower airway. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-250-3330INFO@THAYERMEDICAL.COM

Regulatory Flags#

DUNS number
626238844
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00383480000204SINGLE SPRAY MDI ADAPTER102110212016-09-21
00383480000181SINGLE SPRAY MDI ADAPTER102010202016-09-21
00383480000594LiteAire BASIC180318032024-09-11
00383480000006LITEAIRE13031303, 1304, 13062023-05-09
10383480000003LITEAIRE13031303, 1304, 13062023-05-09
00383480000020VALVED TEE ADAPTER108810882018-09-14
00383480000037VALVED TEE ADAPTER100910092018-09-14
00383480000044VALVED TEE ADAPTER108510852018-09-14
00383480000075MEDLINE VALVED TEE ADAPTERHCSA1008HCSA10082018-09-14
00383480000082MEDLINE VALVED TEE ADAPTERHCSA1009HCSA10092018-09-14
00383480000013VALVED TEE ADAPTER100810082018-09-14
00383480000068QUAKE129712972016-09-21
40383480000493LITEAIRE13031303, 1304, 13062016-09-21
10383480000027VALVED TEE ADAPTER108810882018-09-14
10383480000034VALVED TEE ADAPTER100910092018-09-14
10383480000041VALVED TEE ADAPTER108510852018-09-14
10383480000072MEDLINE VALVED TEE ADAPTERHCSA1008HCSA10082018-09-14
10383480000089MEDLINE VALVED TEE ADAPTERHCSA1009HCSA10092018-09-14
00383480000051PRIMEAIRE111411142016-09-21
10383480000065QUAKE129712972016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
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
00848530102685Nebulizer KitSunset Healthcare Solutions, Inc.NVP2024-08-01
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