aerFree Airway Management System (AMS)

Basic Information

• Brand Name: aerFree Airway Management System (AMS)
• Primary DI: 00851167007001
• Version / Model: 30-5001
• Catalog Number: 30-5001
• Company Name: Sommetrics
• Labeler DUNS: 079606754
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-11
• Public Version: 6
• Public Version Date: 2020-05-05
• Public Version Status: Update
• Public Device Record Key: 43e82e04-21fa-447b-9bed-5b20ff7a2584

Device Description

aerFree AMS utilizes patented aer+TM technology to simply and safely support the patency of the upper airway during medical procedures requiring mild to moderate levels of sedation. It is FDA-cleared for airway management in adults undergoing medical procedures of less than 2 hours in duration, where the patient is intended to receive mild to moderate sedation with non-propofol containing medications.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PMB	External Airway	Anesthesiology	868.5105	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62964	External negative-pressure airway patency collar	A non-sterile, noninvasive device intended to be used to assist upper airway patency of a spontaneously breathing patient by applying external suction to the neck to hold the airway open, typically as an alternative to an artificial airway, continuous positive airway pressure (CPAP) device or chin lift. It consists of a moulded concave collar intended to be worn around the neck to function like a suction cup, and may include connection tubing (for connection to a suction pump); the suction pump is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851167007001	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN140024	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 46 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 59 – 115 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit