Veraseal 2 Full Face AAV Non Vented Mask, Medium

GUDID 10814747021139

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

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use
Primary Device ID10814747021139
NIH Device Record Key2b8bf830-ada8-4657-a7c1-bc6def7e6dd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraseal 2 Full Face AAV Non Vented Mask, Medium
Version Model Number50938
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

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747021132 [Primary]
GS110814747021139 [Package]
Contains: 00814747021132
Package: Case [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-12

On-Brand Devices [Veraseal 2 Full Face AAV Non Vented Mask, Medium]

10814747021139Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure v
10814747020057Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure v
10814747024321Disposable full face non vented mask with anti-asphyxiation valve for use in positive pressure v

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.