FDA.reportPublic FDA data

Mojo Non Vented Full Face Mask, Extra Large with Headgear

Primary DI
00814747022993
Brand
Mojo Non Vented Full Face Mask, Extra Large with Headgear
Company
SLEEPNET, CORP.
Model
50923
Device description
Full face non vented mask for use in positive pressure ventilation.
Published
2022-12-05
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
00814747020197PreviousGS10
00814747022993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747020197008147470201978147470201970814747020197
00814747022993008147470229938147470229930814747022993

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, reusableA 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 and/or 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 reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit122 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
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
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

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Primary DI, Brand, Company table
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