VOCSN PRT-00490-0XX

GUDID 00855573007792

V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

VENTEC LIFE SYSTEMS, INC.

Emergency airway clearance suction system, electric

• Primary Device ID: 00855573007792
• NIH Device Record Key: 7a9f1393-ffea-494b-8790-29492a186aa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN
• Version Model Number: V+O+C+S+N+Pro, English
• Catalog Number: PRT-00490-0XX
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• Device Count: 1
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007006 [Previous]
GS1	00855573007792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162877

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [VOCSN]

• 00855573007006: VOCSN Pro, English: The VOCSN Unified Respiratory System is intended to provide c
• 00855573007792: V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous o
• 00855573007778: V+C+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or inte
• 00855573007747: V+O+C+S+N, English: The VOCSN Unified Respiratory System is intended to provide continuous or in
• 00855573007730: V+C, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermit
• 00855573007211: V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or int
• 00855573007204: V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous
• 00855573007945: V+Pro Emergency, English: The VOCSN Unified Respiratory System is intended to provide continuous
• 00855573007877: V+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or interm
• 00855573007860: V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous o
• 00850018761123: V+C, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermi
• 00850018761130: V+O+C+S+N, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or i
• 00850018761161: V+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or interm
• 00850018761154: V+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or interm
• 00855573007785: V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or int
• 00855573007761: V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous
• 00855573007822: V*Home, English