VOCSN PRT-01201-000

GUDID 00855573007945

V+Pro Emergency, 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. www.VentecLife.com

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007945
• NIH Device Record Key: 78194d1d-3c9f-4b47-a85f-3acd88dcca44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN
• Version Model Number: V+Pro Emergency, English
• Catalog Number: PRT-01201-000
• 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: true
• 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 Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007853 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00855573007945 [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: 2020-04-21
• Device Publish Date: 2020-04-13

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