FDA.reportPublic FDA data

AeroEclipse* BAN*

Primary DI
00604351602250
Brand
AeroEclipse* BAN*
Company
Monaghan Medical Corporation
Model
AE II BAN & Filtered Mouthpiece, cs/25
Device description
AE II BAN with EZ Twist Tubing & Filtered Mouthpiece Kit, cs/25
Published
2023-09-06
Public version status
New
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
K220145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220145000Monaghan medical filtered mouthpiece kitMonaghan Medical Corporation2023-08-24CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50604351602255PackageGS125In Commercial Distribution
00604351602250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060435160225550604351602255
00604351602250006043516022506043516022500604351602250

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, reusableA device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056332380
Device count
1
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

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