AccessGUDID - DEVICE: aerFree Airway Management System (AMS) (00851167007001)

GUDID

Device Identifier (DI) Information

Brand Name: aerFree Airway Management System (AMS)
Version or Model: 30-5001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-5001
Company Name: Sommetrics

Primary DI Number: 00851167007001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079606754 *Terms of Use

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

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:	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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PMB	External Airway

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN140024	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between 15 and 46 Degrees Celsius
Handling Environment Temperature: between 59 and 115 Degrees Fahrenheit
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 43e82e04-21fa-447b-9bed-5b20ff7a2584
Public Version Date: May 05, 2020
Public Version Number: 6
DI Record Publish Date: September 11, 2017