Flexichamber

Basic Information

• Brand Name: Flexichamber
• Primary DI: 00313551000055
• Version / Model: Anti-Static Valved Collapsible Holding Chamber
• Catalog Number: 901-100
• Company Name: AVADEL PHARMACEUTICALS (USA), INC.
• Labeler DUNS: 169886244
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-09
• Public Version: 3
• Public Version Date: 2018-11-08
• Public Version Status: Update
• Public Device Record Key: 44568143-9818-4f99-8a1a-4bea9ed7e91a
• Distribution End Date: 2018-11-07

Device Description

Holding Chambers, Direct Patient Interface

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: 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: 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
NVP	Holding Chambers, 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
Primary	00313551000055	GS1