FDA.reportPublic FDA data

Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Medium Adult

Primary DI
00814747021231
Brand
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Medium Adult
Company
SLEEPNET, CORP.
Model
22640
Device description
Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.
Published
2016-09-13
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
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814747021354PackageGS18In Commercial Distribution
00814747021231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747021354008147470213548147470213540814747021354
00814747021231008147470212318147470212310814747021231

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
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, Small602172026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, Large602212026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, Small602572026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, Large602612026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, Small602232026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, Small602502026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, Large602252026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, Large602522026-06-22
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra Small602222026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, Small602232026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, Medium602242026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, Large602252026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra Small602492026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, Small602502026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, Medium602512026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, Large602522026-06-03
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198843001152bellavistaZoll Medical CorporationCBK2026-06-24
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10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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