VOCSN Internal Bacterial Filter PRT-00976-000

GUDID 00855573007402

VOCSN Internal Bacterial Filter, 10-Pack

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007402
• NIH Device Record Key: 51bc13b9-499e-4c4a-8577-a64ce34a4470
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Internal Bacterial Filter
• Version Model Number: 10-Pack
• Catalog Number: PRT-00976-000
• 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	00855573007402 [Primary]
GS1	00855573007525 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-04
• Device Publish Date: 2019-01-30

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