VOCSN Nurse Call Cable PRT-00820-001

GUDID 00855573007150

VOCSN Nurse Call Cable, Normally Closed

VENTEC LIFE SYSTEMS, INC.

Portable electric ventilator

• Primary Device ID: 00855573007150
• NIH Device Record Key: 5e6913b3-e2cd-4aca-9fd2-6461b385dc92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCSN Nurse Call Cable
• Version Model Number: Normally Closed
• Catalog Number: PRT-00820-001
• 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: 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	00855573007105 [Primary]
GS1	00855573007150 [Package]; Contains: 00855573007105; Package: [10 Units]; In Commercial Distribution

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

On-Brand Devices [VOCSN Nurse Call Cable]

• 00855573007167: VOCSN Nurse Call Cable, Normally Open
• 00855573007150: VOCSN Nurse Call Cable, Normally Closed