Mojo Full Face Mask, Extra Large with Headgear

GUDID 00814747022955

Full face vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable
Primary Device ID00814747022955
NIH Device Record Key7b712d5c-1376-46a8-9cc5-8a6c280287bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMojo Full Face Mask, Extra Large with Headgear
Version Model Number50838
Company DUNS785635186
Company NameSLEEPNET, CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747020159 [Previous]
GS100814747022955 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

On-Brand Devices [Mojo Full Face Mask, Extra Large with Headgear]

00814747020159Full face vented mask for use in positive pressure ventilation.
00814747022955Full face vented mask for use in positive pressure ventilation.
00814747023716Full face vented mask for use in positive pressure ventilation.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.