FDA.reportPublic FDA data

PRIMEAIRE

Primary DI
00383480000051
Brand
PRIMEAIRE
Company
THAYER MEDICAL CORPORATION
Model
1114
Catalog number
1114
Device description
PLASTIC DUAL VALVED HOLDING CHAMBER
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992722000PRIMEAIREThayer Medical Corp.1999-11-10CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383480000058PackageGS110In Commercial Distribution
00383480000051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038348000005810383480000058
00383480000051003834800000513834800000510383480000051

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
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
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
10383480000065QUAKE129712972016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07