FDA.reportPublic FDA data

SuperNO2VA

Primary DI
10889483606032
Brand
SuperNO2VA
Company
AIRLIFE
Model
SSEL-20-CE
Catalog number
SSEL-20-CE
Device description
SuperNO2VA Et Mask, Adult Large
Published
2025-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSJMask, Gas, Anesthetic
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173147000SuperNO2VA Et DeviceRevolutionary Medical Devices, Inc.2018-06-20CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483606036PackageGS120In Commercial Distribution
10889483606032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360603630889483606036
1088948360603210889483606032

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

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
No natural rubber latex
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
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
00840118623681Endure IndustriesENDURE INDUSTRIESBSJ2026-08-14
06946430427496CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427519CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427533CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427557CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427571CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427595CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427618CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
14026704665010HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665188HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665218HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665225HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665232HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665249HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665256HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665263HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665270HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665041RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665065RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665072RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665089RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30
14026704665096RUSCHTELEFLEX INCORPORATEDBSJ2026-07-30