AccessGUDID - DEVICE: SonarMed AirWave (00851334007001)

GUDID

Device Identifier (DI) Information

Brand Name: SonarMed AirWave
Version or Model: AW-M0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SONARMED, INC

Primary DI Number: 00851334007001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198245628 *Terms of Use

Device Description: AirWave Monitor - Portable/handheld monitor packaged with power transformer and electrical cord, data communication cable, reusable sensor cable, hang strap and software CD.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OQU	Airway Monitoring System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf0149e5-9d70-457f-94c6-2872cb1597b5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016