FDA.reportPublic FDA data

LITEAIRE

Primary DI
10383480000003
Brand
LITEAIRE
Company
THAYER MEDICAL CORPORATION
Model
1303
Catalog number
1303, 1304, 1306
Device description
LITEAIRE ENHANCED - DUAL VALVED, COLLAPSIBLE MDI HOLDING CHAMBER (ENHANCED): 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
2023-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NVPHolding Chambers, Direct Patient Interface

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVPHolding Chambers, Direct Patient InterfaceAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383480000003PackageGS125In Commercial Distribution
20383480000000PackageGS11In Commercial Distribution
30383480000007PackageGS14In Commercial Distribution
40383480000004PackageGS1400In Commercial Distribution
50383480000001PackageGS125In Commercial Distribution
00383480000006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038348000000310383480000003
2038348000000020383480000000
3038348000000730383480000007
4038348000000440383480000004
5038348000000150383480000001
00383480000006003834800000063834800000060383480000006

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
626238844
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
00383480000495LITEAIRE13031303, 1304, 13062016-09-21
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
00822383579269DriveDrive Devilbiss HealthcareNVP2025-09-02
10822383579266DriveDrive Devilbiss HealthcareNVP2025-09-02
00604351506121Aerochamber2go Anti-Static Valved Holding ChamberMonaghan Medical CorporationNVP2025-05-30
05023323030054VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-24
05023323029959VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
05023323029973VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
05023323029997VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
05023323030023VentiChamberCLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-10-07
00383480000594LiteAire BASICTHAYER MEDICAL CORPORATIONNVP2024-09-11
00848530102685Nebulizer KitSUNSET HEALTHCARE SOLUTIONS, INC.NVP2024-08-01
05023323029799InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029812InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029829InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-29
05023323029768InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-24
05023323029782InspiraChamber® CLEMENT CLARKE INTERNATIONAL LIMITEDNVP2024-05-24
05023323029751InspiraChamber®FLEXICARE MEDICAL LIMITEDNVP2024-05-17
05023323029775InspiraChamber® FLEXICARE MEDICAL LIMITEDNVP2024-05-17
00762860001138RESPICHAMBER* VHC with MouthpieceTrudell Medical InternationalNVP2024-03-11
10762860001135RESPICHAMBER* VHC with MouthpieceTrudell Medical InternationalNVP2024-03-11
00604351504127Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2024-03-01
50604351504122Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2024-03-01
00604351501126Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351502123Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351503120Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00604351500129Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351501121Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351502128Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
50604351503125Aerochamber Plus® Flow-Vu®Monaghan Medical CorporationNVP2023-11-14
00842135100091Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07
00842135100107Antistatic Compact Space Chamber with Large Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07