FDA.reportPublic FDA data

Mojo 2 Full Face Vented Mask, Large

Primary DI
00814747022016
Brand
Mojo 2 Full Face Vented Mask, Large
Company
SLEEPNET, CORP.
Model
50819
Device description
Full face vented mask for use in positive pressure ventilation.
Published
2019-05-03
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814747022016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814747022016008147470220168147470220160814747022016

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.

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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00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04