VOCSN Patient Air Intake Filters PRT-00977-000

GUDID 00855573007419

VOCSN Patient Air Intake Filters, 25-Pack

VENTEC LIFE SYSTEMS, INC.

Portable oxygen concentrator

• Primary Device ID: 00855573007419
• NIH Device Record Key: d6acf00e-b2fd-41d3-a9af-ed9723ff6511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Patient Air Intake Filters
• Version Model Number: 25-Pack
• Catalog Number: PRT-00977-000
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• Device Count: 25
• 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	00855573007419 [Primary]
GS1	00855573007532 [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

On-Brand Devices [VOCSN Patient Air Intake Filters]

• 00855573007419: VOCSN Patient Air Intake Filters, 25-Pack
• 00855573007532: VOCSN Patient Air Intake Filters, 3-Pack