VOCSN-VC PRT-00900-001

GUDID 00855573007433

VOCSN-VC Pro, English: The VC configuration of VOCSN contains Ventilation and Cough therapies. 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 cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007433
• NIH Device Record Key: 44539961-697b-4781-99ee-f043f0143c38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN-VC
• Version Model Number: VOCSN-VC Pro, English
• Catalog Number: PRT-00900-001
• 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 Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007433 [Primary]

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: 2019-03-28
• Device Publish Date: 2019-01-30

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

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• 00855573007761 - VOCSN: 2022-04-20 V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory supp
• 00855573007785 - VOCSN: 2022-04-20 V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support fo