SonarMed AirWave

Basic Information

• Brand Name: SonarMed AirWave
• Primary DI: 00851334007285
• Version / Model: AW-S085
• Company Name: SONARMED, INC
• Labeler DUNS: 198245628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-08
• Public Version: 1
• Public Version Date: 2021-03-16
• Public Version Status: New
• Public Device Record Key: 15e59249-4da1-4c52-9f5f-54caa5b22334

Device Description

Adult SonarMed Sensor - for use with endotracheal tubes of 8.5 or 9.0 mm ID

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
OQU	Airway Monitoring System	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47544	Endotracheal secretion monitoring system	An assembly of mains electricity (AC-powered) devices designed to continuously detect the sound of endotracheal (ET) secretions moving through a ventilation circuit during suctioning of an artificially ventilated and/or spontaneously breathing patient to asses the effectiveness of suctioning. It typically consists of a disposable sensor (a microphone) connected to the ventilation circuit, and a monitor that displays the signals acoustically and/or visually. It is typically used on cardiac, pulmonary, neurological, postoperative, and trauma patients in a healthcare facility or in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851334007282	GS1	box	5	In Commercial Distribution
Primary	00851334007285	GS1