VOYAGER

GUDID 00814112020296

Voyager Securement Kit for Blood Pump and Oxygenator

CARDIACASSIST, INC.

Cardiopulmonary bypass system mounting unit Cardiopulmonary bypass system mounting unit

• Primary Device ID: 00814112020296
• NIH Device Record Key: bfa2c4ac-a931-48d1-a2c9-df3ea68008e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOYAGER
• Version Model Number: 5170-0000
• Company DUNS: 948683941
• Company Name: CARDIACASSIST, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14129637770
• Email: xxx@xx.xx
• Phone: +14129637770
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814112020296 [Primary]

FDA Product Code

• KRI: Accessory Equipment, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-03
• Device Publish Date: 2015-12-17

On-Brand Devices [VOYAGER]

• 00814112020296: Voyager Securement Kit for Blood Pump and Oxygenator
• 00814112020289: Voyager Securement Kit for Blood Pump