Adult Sotair Device
Basic Information
- Brand Name
- Adult Sotair Device
- Primary DI
- 00860006979607
- Version / Model
- 00
- Company Name
- Safebvm Corp.
- Labeler DUNS
- 117032892
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 1
- Public Version Date
- 2022-11-30
- Public Version Status
- New
- Public Device Record Key
- f69928db-a996-4bd3-a51d-8fb23e99b8a5
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | Anesthesiology | 868.5915 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46634 | Airway pressure monitor, non-powered | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006979607 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212905 | 000 |