Ascend Full Face Airgel Cushion, Medium

GUDID 00814747022511

Replacement cushion for full face vented mask used with positive pressure ventilation.

SLEEPNET, CORP.

CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable CPAP/BPAP face mask, reusable
Primary Device ID00814747022511
NIH Device Record Key900c4e74-83ed-40e0-b2db-2eab7a291940
Commercial Distribution StatusIn Commercial Distribution
Brand NameAscend Full Face Airgel Cushion, Medium
Version Model Number50208
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 Datetrue
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
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx
Phone1-800-742-3646
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100814747022511 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-29
Device Publish Date2020-12-21

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.