HEARTMATE®, DATA CARD 101609

GUDID 00813024010159

Thoratec Corporation

Patient monitoring system module, data memory

• Primary Device ID: 00813024010159
• NIH Device Record Key: 5b9ee98f-d3cc-466b-a942-38683c1b673a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEARTMATE®, DATA CARD
• Version Model Number: 101609
• Catalog Number: 101609
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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 0 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024010159 [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: 4
• Public Version Date: 2019-03-01
• Device Publish Date: 2014-09-20

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