FDA.reportPublic FDA data

SuperNO2VA

Primary DI
10190752145443
Brand
SuperNO2VA
Company
AIRLIFE
Model
SSM-20
Catalog number
SSM-20
Device description
SuperNO2VA Nasal PAP Ventilation System, Medium
Published
2020-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEVCardiopulmonary resuscitation aid kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEVCardiopulmonary Resuscitation Aid KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752145441PackageGS120In Commercial Distribution
10190752145443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075214544150190752145441
1019075214544310190752145443

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194717121022Regard™ROI CPS, LLCOEV2025-02-18
10889483166291SuperNO2VAAIRLIFEOEV2025-02-14
10889483166307SuperNO2VAAIRLIFEOEV2025-02-14
10889483606025SuperNO2VAAIRLIFEOEV2025-02-14
10889483606049SuperNO2VAAIRLIFEOEV2025-02-14
10194717121039Regard™ROI CPS, LLCOEV2025-02-13
10194717121046Regard™ROI CPS, LLCOEV2025-02-13
10194717121053Regard™ROI CPS, LLCOEV2025-02-13
10194717121060Regard™ROI CPS, LLCOEV2025-02-13
10194717120971Regard™ROI CPS, LLCOEV2025-02-10
10194717120988Regard™ROI CPS, LLCOEV2025-02-10
10194717120216Regard™ROI CPS, LLCOEV2024-10-31
10194717120223Regard™ROI CPS, LLCOEV2024-10-31
10194717120254Regard™ROI CPS, LLCOEV2024-10-31
10194717120261Regard™ROI CPS, LLCOEV2024-10-31
10194717120278Regard™ROI CPS, LLCOEV2024-10-31
10194717120230Regard™ROI CPS, LLCOEV2024-10-30
10194717120247Regard™ROI CPS, LLCOEV2024-10-30
10194717120285Regard™ROI CPS, LLCOEV2024-10-30
10194717120186Regard™ROI CPS, LLCOEV2024-10-21
10194717120193Regard™ROI CPS, LLCOEV2024-10-21
10194717120209Regard™ROI CPS, LLCOEV2024-10-21
10194717120001Regard™ROI CPS, LLCOEV2024-10-02
10194717120049Regard™ROI CPS, LLCOEV2024-09-27
10194717119883Regard™ROI CPS, LLCOEV2024-08-01
10194717119876Regard™ROI CPS, LLCOEV2024-07-15
10194717119838Regard™ROI CPS, LLCOEV2024-07-05
10194717119845Regard™ROI CPS, LLCOEV2024-07-05
10194717119777Regard™ROI CPS, LLCOEV2024-06-25
10194717119784Regard™ROI CPS, LLCOEV2024-06-25