FDA.reportPublic FDA data

Aerochamber Plus® Flow-Vu®

Primary DI
50604351503125
Brand
Aerochamber Plus® Flow-Vu®
Company
Monaghan Medical Corporation
Model
aVHC, Large Mask, cs/12
Device description
AC Plus, Flow-Vu aVHC, Large Mask, Retail - 50312
Published
2023-11-14
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
50604351503125PackageGS112In Commercial Distribution
00604351503120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060435150312550604351503125
00604351503120006043515031206043515031200604351503120

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
518-561-7330customerservice@monaghanmed.com

Regulatory Flags#

DUNS number
056332380
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
false
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
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
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
00604351887855MonaghanKit, Teaching, AC Plus® Flow-Vu® aVHC887852018-10-12

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
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
10842135100098Antistatic Compact Space Chamber with Medium Antistatic MaskMEDICAL DEVELOPMENTS INTERNATIONAL LIMITEDNVP2023-08-07