Aura Nasal Vented Mask, Medium

GUDID 00814747020340

Nasal vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP nasal mask, reusable CPAP/BPAP nasal mask, reusable
Primary Device ID00814747020340
NIH Device Record Key7af60493-4bfb-41c7-bbd5-a91eed11c213
Commercial Distribution Discontinuation2019-04-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAura Nasal Vented Mask, Medium
Version Model Number50177
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747020340 [Primary]
GS100814747021828 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-24
Device Publish Date2016-07-05

On-Brand Devices [Aura Nasal Vented Mask, Medium]

00814747020722Nasal vented mask for use in positive pressure ventilation.
00814747020340Nasal vented mask for use in positive pressure ventilation.

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