AccessGUDID - DEVICE: SonarMed AirWave (00851334007254)

GUDID

Device Identifier (DI) Information

Brand Name: SonarMed AirWave
Version or Model: AW-S065
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONARMED, INC

Primary DI Number: 00851334007254
Issuing Agency: GS1
Commercial Distribution End Date: October 22, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 198245628 *Terms of Use

Device Description: Adult SonarMed Sensor - for use with endotracheal tubes of 6.5 or 7.0 mm ID

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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: 6c40582f-8191-45ee-8307-baea895be27a
Public Version Date: October 23, 2025
Public Version Number: 3
DI Record Publish Date: March 08, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851334007251	5	00851334007254	2025-10-22	Not in Commercial Distribution	box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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