FDA.report

MC 300 Reusable Nebulizer

Primary DI
00604351673106
Brand
MC 300 Reusable Nebulizer
Company
Monaghan Medical Corporation
Model
MC300
Device description
MC 300 Reusable Nebulizer, cs/10
Published
2026-05-26
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

Related Records

Contact Domains

Product Codes

CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications

CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions

SubmissionSupplement
K173367000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K173367000MC 300* NebulizerTrudell Medical International2018-02-28CAF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50604351673101PackageGS110In Commercial Distribution
00604351673106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5060435167310150604351673101
00604351673106006043516731066043516731060604351673106

GMDN Terms

TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

Contacts

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

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