AEROCHAMBER* MV Holding Chamber

Basic Information

• Brand Name: AEROCHAMBER* MV Holding Chamber
• Primary DI: 00762860000827
• Version / Model: 82591
• Catalog Number: 825110050
• Company Name: Trudell Medical International
• Labeler DUNS: 203298203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: 8e209644-3f0f-4444-b389-ff6849193c3e

Device Description

AEROCHAMBER* MV Holding Chamber

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	868.5640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65517	Atomizer, ventilatory	A non-powered device intended to accept a medication canister and to be integrated within a mechanical or manual ventilation assembly (e.g., ventilator breathing circuit/endotracheal tube, pulmonary resuscitator) to provide liquid medication in aerosolized form for the patient to breathe during ventilation. It typically includes a medicine chamber spacer; unlike a nebulizer it lacks a baffle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00762860000827	GS1
Package	10762860000824	GS1		50	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K900557	000