Phantom 2 Nasal Vented Mask

GUDID 00814747022801

Nasal vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable
Primary Device ID00814747022801
NIH Device Record Keyf07be32c-369a-4ca1-8b08-c003e53ade6c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhantom 2 Nasal Vented Mask
Version Model Number50182
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 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
GS100814747022801 [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 Date2022-06-09
Device Publish Date2022-06-01

On-Brand Devices [Phantom 2 Nasal Vented Mask]

00814747022801Nasal vented mask for use in positive pressure ventilation.
00814747023907Nasal vented mask for use in positive pressure ventilation.

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