Novaplus Full Face AAV Non Vented Mask, Small

GUDID 00814747023501

Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use CPAP/BPAP face mask, single-use
Primary Device ID00814747023501
NIH Device Record Key1357cf2b-8a06-40ed-ba4f-594177330f1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaplus Full Face AAV Non Vented Mask, Small
Version Model Number50945
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
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 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747023501 [Primary]
GS110814747023508 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-24
Device Publish Date2023-04-14

Devices Manufactured by SLEEPNET, CORP.

00814747023686 - Mojo Full Face Mask, Small with Headgear2024-04-11 Full face vented mask for use in positive pressure ventilation.
00814747023693 - Mojo Full Face Mask, Medium with Headgear2024-04-11 Full face vented mask for use in positive pressure ventilation.
00814747023709 - Mojo Full Face Mask, Large with Headgear2024-04-11 Full face vented mask for use in positive pressure ventilation.
00814747023716 - Mojo Full Face Mask, Extra Large with Headgear2024-04-11 Full face vented mask for use in positive pressure ventilation.
00814747023723 - Mojo Non Vented Full Face Mask, Small with Headgear2024-04-11 Full face non vented mask for use in positive pressure ventilation.
00814747023730 - Mojo Non Vented Full Face Mask, Medium with Headgear2024-04-11 Full face non vented mask for use in positive pressure ventilation.
00814747023747 - Mojo Non Vented Full Face Mask, Large with Headgear2024-04-11 Full face non vented mask for use in positive pressure ventilation.
00814747023761 - Mojo 2 Full Face Vented Mask, Small2024-04-11 Full face vented mask for use in positive pressure ventilation.

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