HeartMate, 14v Li-Ion Battery (SING) 102515-SING

GUDID 00813024012733

Thoratec Corporation

Secondary battery

• Primary Device ID: 00813024012733
• NIH Device Record Key: 8ae4440b-e1be-47cf-9450-0aeecb247ff3
• Commercial Distribution Discontinuation: 2018-05-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HeartMate, 14v Li-Ion Battery (SING)
• Version Model Number: 102515-SING
• Catalog Number: 102515-SING
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024012733 [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: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-08-06

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• 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