BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Evia HF-T

DI: 04035479118372 · Model: 377208 · BIOTRONIK SE & Co. KG

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Evia HF-T
Primary DI: 04035479118372
Version / Model: 377208
Catalog Number: 377208
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: 2014-08-04
Public Version: 4
Public Version Date: 2021-02-05
Public Version Status: Update
Public Device Record Key: b665e8de-a410-405b-8df2-8ba42556d99f
Distribution End Date: 2020-10-16

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	04035479118372	GS1

Customer Contacts

Phone: +1(888)345-0374
Email: [email protected]

Storage Conditions

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