Entrant™

Basic Information

• Brand Name: Entrant™
• Primary DI: 05415067049513
• Version / Model: CDHFA300T
• Catalog Number: CDHFA300T
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 790268031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-25
• Public Version: 1
• Public Version Date: 2024-05-03
• Public Version Status: New
• Public Device Record Key: ea08bca4-fd4c-42da-9ecf-522cb41ac495

Device Description

HF Cardiac Resynchronization Therapy Defibrillator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47270	Cardiac resynchronization therapy implantable defibrillator	An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067049513	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius