Adult Sotair Device

Primary DI
00860006979607
Brand
Adult Sotair Device
Company
Safebvm Corp.
Model
00
Device description
The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The device connects in-line between the bag and the mask, endotracheal tube or other applicable adjunct. In use, when the provider squeezes the bag too forcefully, crossing the maximum flow-limiting safety threshold of air delivered (~ 55 liters-per-minute), the Sotair device’s valve will instantaneously close. The valve remains closed as long as the user is maintaining the force of an unsafe squeeze on the bag. Once the provider releases the grip on the resuscitator bag, the valve will rapidly return to its resting position allowing the user to resume resuscitation at a safe flow.
Published
2022-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212905000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212905000Sotair DeviceSafe Bvm Corporation2022-08-18BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006979607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006979607008600069796078600069796070860006979607

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117032892
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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