LMA ATOMIZATION

Basic Information

• Brand Name: LMA ATOMIZATION
• Primary DI: 14026704717535
• Version / Model: IPN056585
• Catalog Number: AMG600SU
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-30
• Public Version: 1
• Public Version Date: 2020-08-07
• Public Version Status: New
• Public Device Record Key: aec1e56d-cf73-46f1-9c8b-0b0aaa155509

Device Description

MADgic Atomizer with 3 mL Syringe

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: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCT	APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA	Anesthesiology	868.5170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31343	Laryngotracheal anaesthesia applicator	A non-sterile container (e.g., a spray bottle) that is prefilled with an anaesthetic agent and intended to be used to apply the agent to the oropharynx and upper airway, to relax laryngotracheal reflexes prior to an intervention [typically insertion of an endotracheal (ET) tube or other type of tracheal tube]. It is typically used on non-pharmacologically paralyzed patients where multiple reflexes (e.g., the gag reflex, glottic closure, vocal cord spasm, cough reflex, and bronchoconstriction) could make difficult or inhibit safe intervention. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704717532	GS1	Box	25	In Commercial Distribution
Primary	14026704717535	GS1
Package	34026704717539	GS1	Case	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153470	000