VOCSN Carry Bag PRT-01143-000

GUDID 00855573007815

The VOCSN Carry Bag supports everyday mobility with an included shoulder strap and attachment points for securing VOCSN to a wheelchair, bed rail, and other mounts. The Carry Bag is compatible with the VOCSN Roll Stand, the Travel Suction Canister, and other accessories. It also allows access to both removable, rechargeable batteries during use.

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007815
• NIH Device Record Key: f705c51c-8e0e-43ca-a537-45c1a97b74c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Carry Bag
• Version Model Number: Carry Bag
• Catalog Number: PRT-01143-000
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 110 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007815 [Primary]

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: 2019-11-04
• Device Publish Date: 2019-10-25

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

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• 00850018761383 - VOCSN Passive Valve: 2024-12-10
• 00850018761307 - HomeFill® Oxygen System: 2023-10-24
• 00850018761352 - HomeFill® Oxygen System: 2023-10-24
• 00850018761369 - HomeFill® Oxygen System: 2023-10-24
• 00850018761376 - HomeFill® Oxygen System: 2023-10-24
• 00855573007822 - VOCSN: 2023-07-10
• 00850018761291 - PreciseRx™ Pediatric Flowmeter: 2023-06-26