Durata® 7131-65

GUDID 05414734505123

Defibrillation Lead

ST. JUDE MEDICAL, INC.

Endocardial defibrillation lead

• Primary Device ID: 05414734505123
• NIH Device Record Key: a6645242-023d-45ca-8308-af0e2d33d8b5
• Commercial Distribution Discontinuation: 2018-02-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Durata®
• Version Model Number: 7131-65
• Catalog Number: 7131-65
• 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
• 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

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• Handling Environment Temperature: Between -5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734505123 [Primary]
HIBCC	H7587131650 [Secondary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-25

On-Brand Devices [Durata®]

• 05414734505123: Defibrillation Lead
• 05414734505116: Defibrillation Lead
• H75871306009: Defibrillation Lead