AirLife™

Basic Information

• Brand Name: AirLife™
• Primary DI: 10190752142015
• Version / Model: 3T4691A
• Catalog Number: 3T4691A
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-05
• Public Version: 1
• Public Version Date: 2022-09-13
• Public Version Status: New
• Public Device Record Key: 7dbf5e66-a7df-4d65-8d13-2f1714401ff4

Device Description

Basic Tracheostomy Care Kit

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFP	Anesthesia breathing circuit kit (adult & pediatric)	Anesthesiology	868.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14090	Tracheostomy care kit, single-use	A collection of sterile devices and supplies intended to be used for the maintenance of a tracheostomy (i.e., removal and cleaning of tracheostomy tube prior to reinsertion). It typically includes towels, gauze, swabs, cleaning brush, and gloves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50190752142013	GS1		30	In Commercial Distribution
Primary	10190752142015	GS1

Customer Contacts

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