AirLife

Basic Information

• Brand Name: AirLife
• Primary DI: 10190752196506
• Version / Model: AL7023
• Company Name: VYAIRE MEDICAL, INC.
• Labeler DUNS: 080456871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-24
• Public Version: 1
• Public Version Date: 2023-04-03
• Public Version Status: New
• Public Device Record Key: 906be723-5f55-4404-9722-7257b949e852

Device Description

Airlife™ Modudose™ Sterile Water for Inhalation, USP 3 ml

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
44643	Intravenous/irrigation solution storage container, single-use	An empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190752196506	GS1
Package	20190752196503	GS1	Box	100	In Commercial Distribution
Package	50190752196504	GS1	Case	1000	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 77 – 77 Degrees Fahrenheit