Thoratec® HeartMate 3™ 10005877

GUDID 00813024013082

Mini Apical Cuff Kit

Thoratec Corporation

Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system

• Primary Device ID: 00813024013082
• NIH Device Record Key: 2e01dadb-b175-4a55-8527-9fc075ad1d11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoratec® HeartMate 3™
• Version Model Number: 10005877
• Catalog Number: 10005877
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024013082 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-05
• Device Publish Date: 2018-10-19

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