AEROECLIPSE* XL Reusable Breath Actuated Nebulizer

Basic Information

• Brand Name: AEROECLIPSE* XL Reusable Breath Actuated Nebulizer
• Primary DI: 62860105513047
• Version / Model: 105513
• Catalog Number: 10551394050
• Company Name: Trudell Medical International
• Labeler DUNS: 203298203
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-06-29
• Public Version: 3
• Public Version Date: 2020-04-23
• Public Version Status: Update
• Public Device Record Key: 254ec364-2742-40f5-b4b9-5553b5d05e9f
• Distribution End Date: 2020-04-22

Device Description

AEROECLIPSE* XL Reusable Breath Actuated Nebulizer with AeroControl™ System Regulator (package of 50)

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: 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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62042	Nebulizing system delivery set, reusable	A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	62860105513047	GS1
Unit of Use	62860105513030	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080926	000