VOCSN Removable, Rechargeable Battery Set PRT-00980-000

GUDID 00855573007471

VOCSN Removable, Rechargeable Battery Set, Lithium-ion

VENTEC LIFE SYSTEMS, INC.

Emergency airway clearance suction system, electric

• Primary Device ID: 00855573007471
• NIH Device Record Key: 5797734a-045d-43e3-a98c-ad1633dfb164
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Removable, Rechargeable Battery Set
• Version Model Number: Lithium-ion
• Catalog Number: PRT-00980-000
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• Device Count: 2
• 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: false
• Serial Number: true
• 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 Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855573007471 [Primary]
GS1	00855573007495 [Unit of Use]

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: 2
• Public Version Date: 2019-01-31
• Device Publish Date: 2018-10-22

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

• 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
• 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