Thoratec® HeartMate 3™ 106522US

GUDID 05415067030801

Apical Cuff

Thoratec Corporation

Implantable ventricular circulatory assist system

• Primary Device ID: 05415067030801
• NIH Device Record Key: 37b4812c-2049-4d7a-aa10-42cee984160e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoratec® HeartMate 3™
• Version Model Number: 106522US
• Catalog Number: 106522US
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• Device Count: 3
• 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: true
• 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: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024012825 [Unit of Use]
GS1	05415067030801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160054

FDA Product Code

• DSQ: Ventricular (assist) bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-31
• Device Publish Date: 2019-05-23

On-Brand Devices [Thoratec® HeartMate 3™]

• 00813024013082: Mini Apical Cuff Kit
• 00813024013075: Coring Tool
• 05415067031105: System Controller Low Flow 2.0
• 05415067030368: Tunneling Adapter
• 05415067030825: Skin Coring Punch
• 05415067030818: Thread Protectors
• 05415067030801: Apical Cuff
• 00813024013143: Tunneling Lance and Handle