AE II BAN

Basic Information

• Brand Name: AE II BAN
• Primary DI: 00604351600508
• Version / Model: Filtered Mouthpiece, cs/50
• Company Name: Monaghan Medical Corporation
• Labeler DUNS: 056332380
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-25
• Public Version: 8
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: 6da4fca0-9cbb-4645-a9af-798f409440ce
• Distribution End Date: 2023-08-24

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
BYW	Device, Rebreathing	Anesthesiology	868.5675	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43467	Breathing mouthpiece, reusable	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50604351600503	GS1		50	Not in Commercial Distribution	2023-08-24
Primary	00604351600508	GS1

Customer Contacts

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