FDA.reportPublic FDA data

Novaplus Full Face Non Vented Mask, Large

Primary DI
00814747023488
Brand
Novaplus Full Face Non Vented Mask, Large
Company
SLEEPNET, CORP.
Model
50918
Device description
Disposable full face non vented mask for use in positive pressure ventilation.
Published
2023-04-14
Public version status
New
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
10814747023485PackageGS110In Commercial Distribution
00814747023488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081474702348510814747023485
00814747023488008147470234888147470234880814747023488

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 Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

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
Expiration 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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Primary DI, Brand, Company table
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