Kainox 124325

GUDID 04035479011987

Endocardial defibrillation lead

Primary Device ID	04035479011987
NIH Device Record Key	e9c02da5-647f-42b6-9af8-74aeec7ab716
Commercial Distribution Status	In Commercial Distribution
Brand Name	Kainox
Version Model Number	VCS 60
Catalog Number	124325
Company DUNS	315620229
Company Name	BIOTRONIK SE & Co. KG
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	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
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0

Device Issuing Agency	Device ID
GS1	04035479011987 [Primary]

NVY	Permanent defibrillator electrodes

Steralize Prior To Use	false
Device Is Sterile	true

04035479001575 - M-50	2024-10-24
04035479176143 - Home Monitoring Service Center	2024-09-30
04035479184636 - Home Monitoring Service Center	2024-09-23
04035479187163 - Home Monitoring Service Center	2024-09-11
04035479186005 - NEO	2024-06-25
04035479186012 - PSW	2024-06-25
04035479052515 - PK-222 US/2,8m	2024-06-06
04035479186128 - Home Monitoring Service Center	2024-06-06

Mark Image Registration \| Serial	Company Trademark Application Date
KAINOX 75429524 2287242 Dead/Cancelled	BIOTRONIK Mess- und Therapiegeraete GmbH & Co. Ingenieurbuero Berlin 1998-02-05