INBRIJA®

Basic Information

• Brand Name: INBRIJA®
• Primary DI: 00310144300011
• Version / Model: Inbrija Device
• Company Name: Acorda Therapeutics, Inc.
• Labeler DUNS: 963845136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-28
• Public Version: 1
• Public Version Date: 2022-12-06
• Public Version Status: New
• Public Device Record Key: e1d0cf31-04c6-4d02-a798-dcbdd3f0967d

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: Yes
• 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
KCO	Nasal spray, ENT delivery	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38087	Dry powder inhaler	A hand-held device designed to administer powdered medicine through the mouth and into the bronchial airways. Commonly known as a dry powder inhaler (DPI), it is a portable device typically carried in the pocket or a handbag (purse) of a patient for convenient access. This form of medicine administration is an alternative to aerosol inhalation and may induce the patient to greater inhalational effort. This is a reusable device intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310144300011	GS1

Customer Contacts

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