aerFree Airway Management System (AMS)

Primary DI
00851167007001
Brand
aerFree Airway Management System (AMS)
Company
Sommetrics, Inc.
Model
30-5001
Catalog number
30-5001
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.
Published
2017-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PMBExternal Airway

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PMBExternal AirwayAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140024000cNEP AirwaySommetrics2015-12-23PMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851167007001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851167007001008511670070018511670070010851167007001

GMDN Terms#

Term, Definition table
TermDefinition
External negative-pressure airway patency collarA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius46 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit115 Degrees Fahrenheit
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
760-295-5620aehrlich@sommetrics.com
760-295-5620gwinston@sommetrics.com

Regulatory Flags#

DUNS number
079606754
Device count
1
Lot or batch
true
Manufacturing date on label
true