Home GUDID 00814747021330 Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Extra Large Adult
Primary DI 00814747021330
Brand Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Extra Large Adult
Company SLEEPNET, CORP.
Model 22770
Device description Disposable full face vented mask for use in positive pressure ventilation.
Published 2017-05-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name BZD Ventilator, Non-Continuous (Respirator)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BZD Ventilator, Non-Continuous (Respirator) Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814747021330 Package GS1 8 In Commercial Distribution 00814747021286 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00814747021330 00814747021330 814747021330 0814747021330 00814747021286 00814747021286 814747021286 0814747021286
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP face mask, single-use A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth 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/silicone materials that create an airtight seal around the nose and mouth. 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 Type Low High Condition Storage Environment Temperature 0 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 785635186 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00814747024751 MiniMe 2 Pediatric Nasal Vented Mask, Extra Small 60216 2026-05-06 00814747024768 MiniMe 2 Pediatric Nasal Vented Mask, Small 60217 2026-05-06 00814747024775 MiniMe 2 Pediatric Nasal Vented Mask, Medium 60218 2026-05-06 00814747024782 MiniMe 2 Pediatric Nasal Vented Mask, Large 60221 2026-05-06 00814747024799 MiniMe 2 Pediatric Nasal Non Vented Mask, Extra Small 60256 2026-05-06 00814747024805 MiniMe 2 Pediatric Nasal Non Vented Mask, Small 60257 2026-05-06 00814747024812 MiniMe 2 Pediatric Nasal Non Vented Mask, Medium 60258 2026-05-06 00814747024829 MiniMe 2 Pediatric Nasal Non Vented Mask, Large 60261 2026-05-06 00814747024676 Arie Nasal Vented Mask, Small 50149 2026-03-04 00814747024683 Arie Nasal Vented Mask, Medium 50150 2026-03-04 00814747024690 Arie Nasal Vented Mask, Large 50151 2026-03-04 00814747024706 Arie Nasal Vented Mask Kit 50194 2026-03-04 00814747024713 Arie Full Face Vented Mask, Small 50804 2026-03-04 00814747024720 Arie Full Face Vented Mask, Medium 50805 2026-03-04 00814747024737 Arie Full Face Vented Mask, Large 50806 2026-03-04 00814747024744 Arie Full Face Vented Mask Kit 50851 2026-03-04 00814747022887 "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ StableFit Headgear" 50255 2022-07-18 00814747022894 iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear 50575 2022-07-18 00814747022917 iQ Blue Nasal Mask with iQ StableFit Headgear 50655-01 2022-07-18 00814747022849 "iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ 3 Point Headgear" 50250 2022-06-28
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