Entrant™ CDHFA300Q

GUDID 05415067032850

Cardiac Resychronisation Therapy Defibrillator

ST. JUDE MEDICAL, INC.

Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator

• Primary Device ID: 05415067032850
• NIH Device Record Key: 8a242a1f-d9ff-4b3f-91ff-beb3220399af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entrant™
• Version Model Number: CDHFA300Q
• Catalog Number: CDHFA300Q
• Company DUNS: 790268031
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 22 Degrees Celsius and 22 Degrees Celsius
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 72 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage excursions permitted from 59°- 86° F (15°- 30°C).
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067032850 [Primary]

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-10
• Device Publish Date: 2020-09-02

On-Brand Devices [Entrant™]

• 05415067032850: Cardiac Resychronisation Therapy Defibrillator
• 05415067032843: Implantable Cardioverter Defibrillator
• 05415067032836: Implantable Cardioverter Defribrillator
• 05415067049513: HF Cardiac Resynchronization Therapy Defibrillator
• 05415067049469: DR Implantable Cardioverter Defibrillator
• 05415067049414: VR Implantable Cardioverter Defibrillator