Thoratec® HeartMate 3™ Modular Cable Cap 106526US

GUDID 00813024013204

Thoratec Corporation

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00813024013204
• NIH Device Record Key: 49aed280-cd57-4a55-8867-f0ef1d3ad9cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoratec® HeartMate 3™ Modular Cable Cap
• Version Model Number: 106526US
• Catalog Number: 106526US
• Company DUNS: 070156955
• Company Name: Thoratec Corporation
• Device Count: 3
• 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: 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024012986 [Unit of Use]
GS1	00813024013204 [Primary]
GS1	05415067039408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160054

FDA Product Code

• DSQ: Ventricular (Assisst) 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: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-08-30

Devices Manufactured by Thoratec Corporation

• 15415067037807 - HeartMate™: 2025-05-26 14V Li-ion Rechargeable Battery Set
• 05415067037824 - HeartMate™: 2025-05-26 Universal Battery Charger
• 05415067038173 - HeartMate™ GoGear™: 2025-05-26 Shower Bag
• 05415067038609 - HeartMate™: 2025-05-26 Power Module Backup Battery
• 05415067038746 - HeartMate™: 2025-05-26 Apical Coring Knife
• 05415067039040 - HeartMate™: 2025-05-26 14V Li-ion Rechargeable Battery Set
• 15415067039641 - HeartMate™: 2025-05-26 14V Li-ion Battery Clip Set
• 05415067039804 - HeartMate™ GoGear™: 2025-05-26 Holster Vest Medium