RESPOND Ventilator 3461-03-1002

GUDID 00850057117004

CORVENT MEDICAL, INC

Transport electric ventilator

• Primary Device ID: 00850057117004
• NIH Device Record Key: 853acdcd-77d4-4247-b768-c8353882215b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPOND Ventilator
• Version Model Number: RESPOND Ventilator
• Catalog Number: 3461-03-1002
• Company DUNS: 117496308
• Company Name: CORVENT MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com
• Phone: (833)770-8368
• Email: support@corventmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850057117004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241135

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-13
• Device Publish Date: 2025-06-05

On-Brand Devices [RESPOND Ventilator]

• 00850057117004: RESPOND Ventilator
• 00850057117370: RESPOND Ventilator