FDA.reportPublic FDA data

Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Large Adult

Primary DI
00814747020388
Brand
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Large Adult
Company
SLEEPNET, CORP.
Model
22620
Device description
Disposable full face vented mask for use in positive pressure ventilation.
Published
2015-09-25
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814747020388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747020388008147470203888147470203880814747020388

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-742-3646xxx@xx.xx

Regulatory Flags#

DUNS number
785635186
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814747024751MiniMe 2 Pediatric Nasal Vented Mask, Extra Small602162026-05-06
00814747024768MiniMe 2 Pediatric Nasal Vented Mask, Small602172026-05-06
00814747024775MiniMe 2 Pediatric Nasal Vented Mask, Medium602182026-05-06
00814747024782MiniMe 2 Pediatric Nasal Vented Mask, Large602212026-05-06
00814747024799MiniMe 2 Pediatric Nasal Non Vented Mask, Extra Small602562026-05-06
00814747024805MiniMe 2 Pediatric Nasal Non Vented Mask, Small602572026-05-06
00814747024812MiniMe 2 Pediatric Nasal Non Vented Mask, Medium602582026-05-06
00814747024829MiniMe 2 Pediatric Nasal Non Vented Mask, Large602612026-05-06
00814747024676Arie Nasal Vented Mask, Small501492026-03-04
00814747024683Arie Nasal Vented Mask, Medium501502026-03-04
00814747024690Arie Nasal Vented Mask, Large501512026-03-04
00814747024706Arie Nasal Vented Mask Kit501942026-03-04
00814747024713Arie Full Face Vented Mask, Small508042026-03-04
00814747024720Arie Full Face Vented Mask, Medium508052026-03-04
00814747024737Arie Full Face Vented Mask, Large508062026-03-04
00814747024744Arie Full Face Vented Mask Kit508512026-03-04
00814747022887"iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ StableFit Headgear"502552022-07-18
00814747022894iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear505752022-07-18
00814747022917iQ Blue Nasal Mask with iQ StableFit Headgear50655-012022-07-18
00814747022849"iQ Blue Nasal Mask & 6"" Tapered Tubing with iQ 3 Point Headgear"502502022-06-28

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