VOCSN Passive Valve PRT-01450-000

GUDID 00850018761383

VENTEC LIFE SYSTEMS, INC.

In-exsufflator

• Primary Device ID: 00850018761383
• NIH Device Record Key: 975ffdb9-bf1f-455d-807a-e602bfdf1fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Passive Valve
• Version Model Number: Passive Valve
• Catalog Number: PRT-01450-000
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018761383 [Primary]
GS1	00850018761390 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162877

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: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

• 00850018761321 - Platinum® 10L Oxygen Concentrator: 2024-12-30
• 00850018761383 - VOCSN Passive Valve: 2024-12-10
• 00850018761383 - VOCSN Passive Valve: 2024-12-10
• 00850018761307 - HomeFill® Oxygen System: 2023-10-24
• 00850018761352 - HomeFill® Oxygen System: 2023-10-24
• 00850018761369 - HomeFill® Oxygen System: 2023-10-24
• 00850018761376 - HomeFill® Oxygen System: 2023-10-24
• 00855573007822 - VOCSN: 2023-07-10
• 00850018761291 - PreciseRx™ Pediatric Flowmeter: 2023-06-26