Veraseal 3 Full Face Vented Mask, Small

GUDID 00814747021453

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

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use
Primary Device ID00814747021453
NIH Device Record Key88702ca0-1304-497c-aaa2-a3c4f63f285e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraseal 3 Full Face Vented Mask, Small
Version Model Number50843
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
GS100814747021453 [Primary]
GS110814747021450 [Package]
Package: Case [10 Units]
In Commercial Distribution

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 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.

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