EasiVENT Valved Holding Chamber

Basic Information

• Brand Name: EasiVENT Valved Holding Chamber
• Primary DI: 00349502207013
• Version / Model: 49502-207
• Company Name: Mylan Specialty L.P.
• Labeler DUNS: 194775557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-10
• Public Version: 3
• Public Version Date: 2022-01-21
• Public Version Status: Update
• Public Device Record Key: 8ff4e971-7aa1-4a5c-9f86-d0bc7a61c5fd

Device Description

Easivent Valved Holding Chamber is designed to assist with Metered Dose Inhaler (MDI) aerosol medication delivery. It is comprised of a MDI adapter port, Holding chamber, a one way valve, Mouth Piece and mouthpiece cap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• 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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38018	Medicine chamber spacer, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30349502207014	GS1		12	In Commercial Distribution
Primary	00349502207013	GS1
Package	30349502207250	GS1		25	In Commercial Distribution

Customer Contacts

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