BK-IS4/DF4 395399

GUDID 04035479132613

Pacing/defibrillation lead cap

Primary Device ID	04035479132613
NIH Device Record Key	00c946c9-72d7-4b86-9679-bbc861d6408b
Commercial Distribution Status	In Commercial Distribution
Brand Name	BK-IS4/DF4
Version Model Number	395399
Catalog Number	395399
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	true
Serial Number	false
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
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	04035479132613 [Primary]

NVY	Permanent defibrillator electrodes

Steralize Prior To Use	false
Device Is Sterile	true

04035479119751	378456
04035479132613	395399