RESPOND Ventilator Kit 91-101-US101

GUDID 00850057117011

CORVENT MEDICAL, INC

Transport electric ventilator
Primary Device ID00850057117011
NIH Device Record Key808f9862-f569-4e4b-a303-a6253cc4b981
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESPOND Ventilator Kit
Version Model NumberRESPOND Ventilator Kit
Catalog Number91-101-US101
Company DUNS117496308
Company NameCORVENT MEDICAL, INC
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com
Phone(833)7708368
Emailsupport@corventmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850057117011 [Primary]

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
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.