HeartMate™ 109200

GUDID 05415067038609

Power Module Backup Battery

Thoratec Corporation

Secondary battery

• Primary Device ID: 05415067038609
• NIH Device Record Key: fba88ac3-09f7-438c-8fb2-4a419182555b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartMate™
• Version Model Number: 109200
• Catalog Number: 109200
• 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: 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
• 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 -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 105 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067038609 [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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-26
• Device Publish Date: 2025-05-16

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• 05415067038609: Power Module Backup Battery
• 05415067037824: Universal Battery Charger
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