LTV2 Ventilator 30509-001

GUDID 10190752130364

TABLE STAND, LTV/LTV2

VYAIRE MEDICAL, INC.

Desk mount

• Primary Device ID: 10190752130364
• NIH Device Record Key: b886e17a-a1bf-4142-811a-b4459c815d1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LTV2 Ventilator
• Version Model Number: 30509-001
• Catalog Number: 30509-001
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752130364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060647

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: 2025-07-24
• Device Publish Date: 2025-07-16

On-Brand Devices [LTV2 Ventilator]

• 10190752190368: Teleflex Humidifier Mounting bracket
• 10190752188808: Teleflex Humidifier Mounting bracket
• 10190752188761: Cable Assy, LTV2, Nurse Call N-C
• 10190752188754: Nurse Call Cable, Normally Open
• 10190752130364: TABLE STAND, LTV/LTV2