VOCSN Roll Stand PRT-00569-000

GUDID 00855573007174

VOCSN Roll Stand

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007174
• NIH Device Record Key: 1a46c941-8ec1-461b-9baf-0d946dfbda3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Roll Stand
• Version Model Number: PRT-00569-000
• Catalog Number: PRT-00569-000
• 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: 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	00855573007174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162877

FDA Product Code

• NOU: Continuous, Ventilator, Home 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-11

On-Brand Devices [VOCSN Roll Stand]

• 00855573007174: VOCSN Roll Stand
• 00855573007907: VOCSN Roll Stand