THORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, RIGHT 104233

GUDID 00813024011156

Thoratec Corporation

Personal device holder, reusable

• Primary Device ID: 00813024011156
• NIH Device Record Key: def31be2-d454-4b68-8d8b-d3265a8620cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, RIGHT
• Version Model Number: 104233
• Catalog Number: 104233
• 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: 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: +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
• 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
• 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
• 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
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024011156 [Primary]
GS1	05415067039842 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-12-11
• Device Publish Date: 2014-09-20

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• 05415067039903 - HeartMate™ GoGear™: 2025-07-29 Wearable Accessories Kit
• 05415067039422 - HeartMate 3™: 2025-07-24 System Controller Low Flow 2.0
• 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