Durata™ 7120-65

GUDID 05414734502092

Defibrillation Lead

ST. JUDE MEDICAL, INC.

Endocardial defibrillation lead

• Primary Device ID: 05414734502092
• NIH Device Record Key: de63dbdb-b3c5-4ae0-a840-62297b44a288
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durata™
• Version Model Number: 7120-65
• Catalog Number: 7120-65
• 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

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
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French
• Length: 65 Centimeter
• Catheter Gauge: 7 French

Operating and Storage Conditions

• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Handling Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• 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 -5 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Yes
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734502092 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-24

On-Brand Devices [Durata™]

• 05414734505130: Defibrillation Lead
• 05414734505109: Defibrillation Lead
• 05414734503730: Defibrillation Lead
• 05414734503341: Defibrillation Lead
• 05414734503297: Defibrillation Lead
• 05414734503280: Defibrillation Lead
• 05414734503273: Defibrillation Lead
• 05414734503266: Defibrillation Lead
• 05414734503259: Defibrillation Lead
• 05414734503242: Defibrillation Lead
• 05414734503228: Defibrillation Lead
• 05414734503211: Defibrillation Lead
• 05414734503204: Defibrillation Lead
• 05414734503174: Defibrillation Lead
• 05414734503167: Defibrillation Lead
• 05414734503037: Defibrillation Lead
• 05414734502818: Defibrillation Lead
• 05414734502443: Defibrillation Lead
• 05414734502436: Defibrillation Lead
• 05414734502160: Defibrillation Lead
• 05414734502153: Defibrillation Lead
• 05414734502146: Defibrillation Lead
• 05414734502139: Defibrillation Lead
• 05414734502122: Defibrillation Lead
• 05414734502115: Defibrillation Lead
• 05414734502108: Defibrillation Lead
• 05414734502092: Defibrillation Lead
• 05414734502085: Defibrillation Lead