Veraseal 3 Full Face Vented Mask, Large

GUDID 10814747021474

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

SLEEPNET, CORP.

CPAP/BPAP face mask, single-use
Primary Device ID10814747021474
NIH Device Record Keyb216cd7a-4bdc-4585-b3e8-1ab043b2bfaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraseal 3 Full Face Vented Mask, Large
Version Model Number50845
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
GS100814747021477 [Primary]
GS110814747021474 [Package]
Contains: 00814747021477
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.

00814747023181 - Mojo 2 Full Face Vented Mask, Small2023-04-28 Full face vented mask for use in positive pressure ventilation.
00814747023198 - Mojo 2 Full Face Vented Mask, Medium2023-04-28 Full face vented mask for use in positive pressure ventilation.
00814747023204 - Mojo 2 Full Face Vented Mask, Large2023-04-28 Full face vented mask for use in positive pressure ventilation.
00814747023211 - Mojo 2 Full Face Vented Mask, Extra Large2023-04-28 Full face vented mask for use in positive pressure ventilation.
00814747023228 - Mojo 2 Full Face Non Vented Mask, Small2023-04-28 Full face non vented mask for use in positive pressure ventilation.
00814747023235 - Mojo 2 Full Face Non Vented Mask, Medium2023-04-28 Full face non vented mask for use in positive pressure ventilation.
00814747023242 - Mojo 2 Full Face Non Vented Mask, Large2023-04-28 Full face non vented mask for use in positive pressure ventilation.
00814747023259 - Mojo 2 Full Face Mask Non Vented Mask, Extra Large2023-04-28 Full face non vented mask for use in positive pressure ventilation.

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