FDA.reportPublic FDA data

Novaplus Full Face Non Vented Mask, Extra Large

Primary DI
00814747025277
Brand
Novaplus Full Face Non Vented Mask, Extra Large
Company
SLEEPNET, CORP.
Model
50919
Device description
Disposable full face non vented mask for use in positive pressure ventilation.
Published
2026-10-23
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

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
00814747024423PreviousGS10
00814747025277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747024423008147470244238147470244230814747024423
00814747025277008147470252778147470252770814747025277

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814747025017Arie Full Face Vented Mask Kit651002026-10-23
00814747025024Arie Full Face Vented Mask, Small651012026-10-23
00814747025031Arie Full Face Vented Mask, Medium651022026-10-23
00814747025048Arie Full Face Vented Mask, Large651032026-10-23
00814747025055Ascend Full Face Vented Mask Kit651042026-10-23
00814747025062Ascend Full Face Vented Mask, Small651052026-10-23
00814747025079Ascend Full Face Vented Mask, Medium651062026-10-23
00814747025086Ascend Full Face Vented Mask, Large651072026-10-23
00814747025093Arie Nasal Vented Mask Kit652002026-10-23
00814747025109Arie Nasal Vented Mask, Small652012026-10-23
00814747025116Arie Nasal Vented Mask, Medium652022026-10-23
00814747025123Arie Nasal Vented Mask, Large652032026-10-23
00814747025130Ascend Nasal Vented Mask Kit652042026-10-23
00814747025147Ascend Nasal Vented Mask, Small652052026-10-23
00814747025154Ascend Nasal Vented Mask, Small652062026-10-23
00814747025161Ascend Nasal Vented Mask, Large652072026-10-23
00814747025178IQ 2 Nasal Mask652082026-10-23
00814747025185Phantom 2 Nasal Vented Mask652092026-10-23
00814747025192MiniMe 2 Pediatric Nasal Vented Mask, Extra Small653002026-10-23
00814747025208MiniMe 2 Pediatric Nasal Vented Mask, Small653012026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814747025239Novaplus Full Face AAV Non Vented Mask, Extra LargeSLEEPNET, CORP.CBK2026-10-23
00814747025246Novaplus Full Face AAV Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025253Novaplus Full Face AAV Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025260Novaplus Full Face AAV Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
00814747025284Novaplus Full Face Non Vented Mask, LargeSLEEPNET, CORP.CBK2026-10-23
00814747025291Novaplus Full Face Non Vented Mask, MediumSLEEPNET, CORP.CBK2026-10-23
00814747025307Novaplus Full Face Non Vented Mask, SmallSLEEPNET, CORP.CBK2026-10-23
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