RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/ 91-101-US504

GUDID 00850057117417

CORVENT MEDICAL, INC

Ventilator breathing circuit, single-use

• Primary Device ID: 00850057117417
• NIH Device Record Key: 389571e7-1591-4372-90d8-bf825202fcbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/
• Version Model Number: RESPOND HME Patient Circuit Kit (Tubing, Connector
• Catalog Number: 91-101-US504
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850057117417 [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: 2026-01-14
• Device Publish Date: 2026-01-06

Devices Manufactured by CORVENT MEDICAL, INC

• 00850057117370 - RESPOND Ventilator: 2026-01-14
• 00850057117387 - Flow Sensor: 2026-01-14
• 00850057117394 - RESPOND Exhalation Manifold: 2026-01-14
• 00850057117400 - Exhalation Valve: 2026-01-14
• 00850057117417 - RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/: 2026-01-14
• 00850057117417 - RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/: 2026-01-14
• 00850057117424 - HEPA Filters: 2026-01-14
• 00850057117448 - Green Oxygen Hose, 8ft: 2026-01-14
• 00850057117455 - Oxygen Tubing with Connector, 7ft: 2026-01-14