VOCSN External Bacterial Filter PRT-00790-002

GUDID 00855573007198

VOCSN External Bacterial Filter

VENTEC LIFE SYSTEMS, INC.

In-exsufflator

• Primary Device ID: 00855573007198
• NIH Device Record Key: 727cba0f-7b59-4faf-a59a-faf6b09c76a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN External Bacterial Filter
• Version Model Number: PRT-00790-001
• Catalog Number: PRT-00790-002
• 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: true
• 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	00855573007013 [Primary]
GS1	00855573007198 [Package]; Contains: 00855573007013; Package: [10 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-31
• Device Publish Date: 2017-11-11

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