VOCSN Humidifier Bypass PRT-00832-001

GUDID 00855573007136

VOCSN Humidifier Bypass (Blue)

VENTEC LIFE SYSTEMS, INC.

In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator In-exsufflator

• Primary Device ID: 00855573007136
• NIH Device Record Key: efb6c921-d490-4778-9b1a-ec6e34629c6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Humidifier Bypass
• Version Model Number: Blue
• Catalog Number: PRT-00832-001
• 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: 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	00855573007136 [Primary]
GS1	00855573007372 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	00855573007976 [Package]; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162877

FDA Product Code

• NHJ: Device, Positive Pressure Breathing, Intermittent

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

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

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• 00850018761376 - HomeFill® Oxygen System: 2023-10-24
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• 00850018761291 - PreciseRx™ Pediatric Flowmeter: 2023-06-26
• 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