Revel

GUDID 10190752157071

REVEL Ventilator

VYAIRE MEDICAL, INC.

Neonatal/adult intensive-care ventilator

• Primary Device ID: 10190752157071
• NIH Device Record Key: 2c508df1-bbae-431e-a71c-3cb96d4a33c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revel
• Version Model Number: 19260-001
• Company DUNS: 080456871
• Company Name: VYAIRE 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: true
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752157071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103211

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: 2024-03-28
• Device Publish Date: 2024-03-20

Devices Manufactured by VYAIRE MEDICAL, INC.

• 10190752191518 - bellavista: 2025-08-05 bellaivsta Nurse Call Cable Normally Open
• 10190752188860 - bellavista: 2025-08-04 bellaivsta Nurse Call Connector
• 10190752191525 - bellavista: 2025-08-04 bellaivsta Nurse Call Connector
• 10190752130364 - LTV2 Ventilator: 2025-07-24 TABLE STAND, LTV/LTV2
• 20190752201061 - 3100A HFOV: 2025-07-24 FILTER PK10 3100A
• 10190752185197 - LTV2: 2025-07-24 O2 CYLINDER MOUNT, LTV2 FLOOR STAND
• 10190752188754 - LTV2 Ventilator: 2025-07-24 Nurse Call Cable, Normally Open
• 10190752188761 - LTV2 Ventilator: 2025-07-24 Cable Assy, LTV2, Nurse Call N-C