TLC-II® SYSTEM DRIVER 100621

GUDID 00813024013396

Thoratec Corporation

Implantable ventricular circulatory assist system control unit

• Primary Device ID: 00813024013396
• NIH Device Record Key: d0d5067a-0b64-48ac-923d-8a63636713a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLC-II® SYSTEM DRIVER
• Version Model Number: 100621
• Catalog Number: 100621
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024013396 [Primary]

FDA Product Code

• DSQ: Ventricular (Assisst) 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: 7
• Public Version Date: 2019-03-21
• Device Publish Date: 2014-09-20

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• 05415067039286 - HeartMate 3™: 2022-06-22 Apical Cuff
• 05415067039361 - HeartMate 3™: 2022-06-22 Skin Coring Punch
• 15415067039481 - HeartMate 3™: 2022-06-22 Thread Protectors
• 05415067033758 - HeartMate Touch™: 2020-07-02 Communication System
• 05415067032058 - HeartMate Touch™: 2020-05-12 Communication System