SonarMed AirWave

Basic Information

• Brand Name: SonarMed AirWave
• Primary DI: 00851334007292
• Version / Model: AW-SC05
• 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: 2
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 40438e47-ba86-4327-84a8-73e3c7f64cee

Device Description

AirWave Reusable Sensor Cable - for Use with All Sizes of the AirWave Sensor

Device Characteristics

• Single Use: No
• 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: 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
Primary	00851334007292	GS1