FDA.reportPublic FDA data

SuperNO2VA

Primary DI
10889483606025
Brand
SuperNO2VA
Company
AIRLIFE
Model
SSEL-20
Catalog number
SSEL-20
Device description
SuperNO2VA ET SYSTEM, Adult Large
Published
2025-02-14
Public version status
Update
Distribution status
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
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
30889483606029PackageGS120In Commercial Distribution
10889483606025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360602930889483606029
1088948360602510889483606025

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, single-useA non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 ml0026200026202025-02-20
10889483617007AirLife™RC6Y023034RC6Y0230342025-02-27
10889483618264Air LifeAM-20002026-08-26
10889483618271Air LifeAM-21002026-08-26
10889483618288Air LifeAM-22002026-08-26
10889483618295Air LifeAM-30002026-08-26
10889483618301Air LifeAM-31002026-08-26
10889483618318Air LifeAM-32002026-08-26
10190752118379Vital Signs™2L39882L39882019-12-20
10190752118430Vital Signs™5030AE5030AE2020-02-20
10190752118973Vital Signs™5236AAE5236AAE2019-12-20
10190752119017Vital Signs™5372AE5372AE2019-12-20
10190752119215Vital Signs™A1UXOXXXA1UXOXXX2019-12-20
10190752119246Vital Signs™A1ZX1XXXA1ZX1XXX2020-02-20
10190752119369Vital Signs™A46517XXA46517XX2019-12-20
10190752119437Vital Signs™A46X8XXXA46X8XXX2019-12-20
10190752119628Vital Signs™A4FX1XXXA4FX1XXX2019-12-20
10190752119680Vital Signs™A4FX20X4VA4FX20X4V2020-02-20

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
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
10194717118176Regard™ROI CPS, LLCOEV2024-02-29