RESPOND Ventilator Kit w/o Battery 91-101-US102

GUDID 00850057117028

CORVENT MEDICAL, INC

Transport electric ventilator
Primary Device ID00850057117028
NIH Device Record Keyd864cf6d-8e52-45dd-a137-15e0b6f50c58
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESPOND Ventilator Kit w/o Battery
Version Model NumberRESPOND Ventilator Kit w/o Battery
Catalog Number91-101-US102
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)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
GS100850057117028 [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
00850057117028 - RESPOND Ventilator Kit w/o Battery2025-06-13
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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