Novaplus Hospital Nasal Vented Mask, s/m

GUDID 00814747023389

Disposable nasal vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use CPAP/BPAP nasal mask, single-use
Primary Device ID00814747023389
NIH Device Record Key811fd7c6-48cb-4b69-832e-3682d2e0b494
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovaplus Hospital Nasal Vented Mask, s/m
Version Model Number50155
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

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
GS100814747023389 [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 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.

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