HME Filters 91-101-US306

GUDID 00850057117325

CORVENT MEDICAL, INC

Heat/moisture exchanger insertable filter
Primary Device ID00850057117325
NIH Device Record Key0bf5d690-5c82-4b32-8037-f778a905fee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHME Filters
Version Model NumberHME Filters
Catalog Number91-101-US306
Company DUNS117496308
Company NameCORVENT MEDICAL, INC
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com
Phone(833)770-8368
Emailsupport@corventmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850057117196 [Primary]
GS100850057117325 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBKVentilator, Continuous, Facility Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-13
Device Publish Date2025-06-05

Devices Manufactured by CORVENT MEDICAL, INC

00850057117004 - RESPOND Ventilator2025-06-13
00850057117011 - RESPOND Ventilator Kit2025-06-13
00850057117028 - RESPOND Ventilator Kit w/o Battery2025-06-13
00850057117035 - RESPOND Ventilator Kit w/ Rugged Case2025-06-13
00850057117042 - RESPOND Power Supply (US)2025-06-13
00850057117349 - RESPOND Exhalation Manifold2025-06-13
00850057117066 - Nurse Call Cable, Normally Open2025-06-13
00850057117073 - Serial EHR Cable2025-06-13

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