FDA.report

Novaplus Full Face AAV Non Vented Mask, Medium

Primary DI
10814747024444
Brand
Novaplus Full Face AAV Non Vented Mask, Medium
Company
SLEEPNET, CORP.
Model
50946
Device description
Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.
Published
2025-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications

CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10814747024444PackageGS110In Commercial Distribution
00814747023518PreviousGS10
00814747024447PrimaryGS10

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-742-3646xxx@xx.xx

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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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
00814747024614MiniMe Pediatric Mask with Headgear, Size Small602132025-05-06
00814747024621MiniMe Pediatric Mask with Headgear, Size Medium602142025-05-06
00814747024638MiniMe Pediatric Mask with Headgear, Size Large602152025-05-06
00814747024645MiniMe Pediatric Ventilation Mask with Headgear, Size Small602532025-05-06
00814747024652MiniMe Pediatric Ventilation Mask with Headgear, Size Medium602542025-05-06
00814747024669MiniMe Pediatric Ventilation Mask with Headgear, Size Large602552025-05-06
10814747024598Veraseal 2 Full Face Vented Mask, Extra Large508302025-02-11
10814747024413Novaplus Full Face Non Vented Mask, Large509182025-02-05
00814747024355Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult226302025-02-04
00814747024379Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Medium Adult226402025-02-04
10814747024390Novaplus Full Face Non Vented Mask, Small509162025-02-04
10814747024406Novaplus Full Face Non Vented Mask, Medium509172025-02-04

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