Inspirachamber with InspiraMask (Large)

Basic Information

• Brand Name: Inspirachamber with InspiraMask (Large)
• Primary DI: 00852367007013
• Version / Model: IC-IML-0
• Company Name: INSPIRX, INC
• Labeler DUNS: 967174850
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-18
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1f75d8ef-96b9-4932-a441-ceff33f2322d

Device Description

InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit

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: 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
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	00852367007013	GS1
Package	10852367007010	GS1		10	In Commercial Distribution