Thorate® VAD, Surgical Implant Accessory Kit 20002-2615-001

GUDID 00813024013129

Thoratec Corporation

Cardiothoracic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00813024013129
• NIH Device Record Key: 82420577-e995-428d-9103-9b4185b5b2a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thorate® VAD, Surgical Implant Accessory Kit
• Version Model Number: 20002-2615-001
• Catalog Number: 20002-2615-001
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813024013129 [Primary]

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: 4
• Public Version Date: 2019-05-16
• Device Publish Date: 2014-09-20

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