VOCSN O2 Low Pressure Inlet PRT-00981-000

GUDID 00855573007396

VOCSN O2 Low Pressure Inlet, 10-Pack

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007396
• NIH Device Record Key: 6ab8e7c7-f9d8-4761-9124-c5d52bf9348b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN O2 Low Pressure Inlet
• Version Model Number: 10-Pack
• Catalog Number: PRT-00981-000
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007396 [Primary]
GS1	00855573007518 [Unit of Use]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-07-13

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

• 00850018761321 - Platinum® 10L Oxygen Concentrator: 2024-12-30
• 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