Durata™ 7170-65

GUDID 05414734502436

Defibrillation Lead

ST. JUDE MEDICAL, INC.

Endocardial defibrillation lead

• Primary Device ID: 05414734502436
• NIH Device Record Key: a12ed0f2-f381-4239-8cf0-ec0829ccbe0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durata™
• Version Model Number: 7170-65
• Catalog Number: 7170-65
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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
• 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

Device Dimensions

• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).
• Special Storage Condition, Specify: Between 0 and 0 *The lead should be stored at room temperature between 20C to 25C (68F to 77F). Excursions are permitted between 15C to 30C (59F to 86F).

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734502436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950022

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-09
• Device Publish Date: 2017-02-02

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