FDA.reportPublic FDA data

Nasoneb®

Primary DI
00604351708006
Brand
Nasoneb®
Company
Monaghan Medical Corporation
Model
Sinus Therapy System Supply Kit
Published
2022-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50604351708001PackageGS11In Commercial Distribution
00604351708006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060435170800150604351708001
00604351708006006043517080066043517080060604351708006

GMDN Terms#

Term, Definition table
TermDefinition
Nasal irrigation set, home-useA collection of non-sterile items intended to dispense a solution to penetrate, clear, and clean the nasal passages and sinus cavity for the relief of nasal and sinus symptoms (e.g., nasal congestion, sinus pressure, secretions, nasopharyngeal discharge, encrustations, nasal dryness); it may also be used to create a solution. It typically includes an irrigation bottle/canister, actuator tips and adaptors for various solution-delivery applications, and sometimes packets of sodium-based solutes or prepared solution. It is intended for use in the home. After application, the solution cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
518-561-7330customerservice@monaghanmed.com

Regulatory Flags#

DUNS number
056332380
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00604351673106MC 300 Reusable NebulizerMC3002026-05-26
00604351506121Aerochamber2go Anti-Static Valved Holding ChamberAeroChamber2go, cs/122025-05-30
00604351505124Aerobika,OPEP Aerobika, OPEP Device, Retail2024-05-16
00604351707061Nasoneb®NasoNeb Sinus Therapy System cs/62024-10-25
50604351707066Nasoneb®NasoNeb Sinus Therapy System cs/62024-10-25
50604351505129Aerobika,OPEP Aerobika, OPEP Device, Retail2024-05-16
00604351350014Nasoneb®NasoNeb Compressor2024-04-09
00604351504127Aerochamber Plus® Flow-Vu®aVHC, Intermediate Mask, cs/122024-03-01
50604351504122Aerochamber Plus® Flow-Vu®aVHC, Intermediate Mask, cs/122024-03-01
00604351501126Aerochamber Plus® Flow-Vu®aVHC, Small Mask, cs/122023-11-14
00604351502123Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, cs/122023-11-14
00604351503120Aerochamber Plus® Flow-Vu®aVHC, Large Mask, cs/122023-11-14
00604351500129Aerochamber Plus® Flow-Vu®aVHC, Mouthpiece, cs/122023-11-14
50604351501121Aerochamber Plus® Flow-Vu®aVHC, Small Mask, cs/122023-11-14
50604351502128Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, cs/122023-11-14
50604351503125Aerochamber Plus® Flow-Vu®aVHC, Large Mask, cs/122023-11-14
00604351886858MonaghanKit, Educational, MMC Z STAT™ aVHC886852018-10-12
00604351788015Aerochamber Plus® Flow-Vu®aVHC, Medium Mask, NFR, Single2016-10-10
00604351798014Aerochamber Plus® Flow-Vu®aVHC, Mouthpiece, NFR, Single2016-10-10
00604351808010Aerochamber Plus® Flow-Vu®aVHC, Large Mask, NFR, Single2016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
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10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
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10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07