LMA ATOMIZATION

Basic Information

• Brand Name: LMA ATOMIZATION
• Primary DI: 05060112313134
• Version / Model: IPN046390
• Catalog Number: MAD510
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-15
• Public Version: 3
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: bef7f850-cd73-4faa-b205-dca0e440fd2b

Device Description

MADomizer Disposable Tip

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCQ	NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)	Anesthesiology	868.5640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10226	Atomizer, non-ventilatory	A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060112313138	GS1	Case	4	Not in Commercial Distribution	2019-09-30
Package	15060112313131	GS1	Bag-In-Box or BIB	50	Not in Commercial Distribution	2019-09-30
Primary	05060112313134	GS1

Customer Contacts

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