Eluna 8 HF-T

Basic Information

• Brand Name: Eluna 8 HF-T
• Primary DI: 04035479131753
• Version / Model: 394917
• Catalog Number: 394917
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-12-09
• Public Version: 5
• Public Version Date: 2021-08-25
• Public Version Status: Update
• Public Device Record Key: 1e54c879-1fac-4424-b363-66fb1a419d7c
• Distribution End Date: 2021-08-24

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: Labeling does not contain MRI Safety Information
• 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
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47263	Cardiac resynchronization therapy implantable pacemaker	A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479131753	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P950037	137

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 113 Degrees Fahrenheit