Veraseal 3 Full Face Non Vented Mask, Medium

GUDID 10814747021504

Disposable full face non vented mask for use in positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use
Primary Device ID10814747021504
NIH Device Record Keyf8c4f671-41d6-4653-aefe-bd16129bd9b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraseal 3 Full Face Non Vented Mask, Medium
Version Model Number50950
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747021507 [Primary]
GS110814747021504 [Package]
Contains: 00814747021507
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 Date2019-12-13
Device Publish Date2019-05-03

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.