DH IS-1/DF4 401297

GUDID 04035479138516

Endocardial defibrillation lead

Primary Device ID	04035479138516
NIH Device Record Key	1b0f489c-d38b-4e4a-a856-425ada878dd0
Commercial Distribution Status	In Commercial Distribution
Brand Name	DH IS-1/DF4
Version Model Number	401297
Catalog Number	401297
Company DUNS	315620229
Company Name	BIOTRONIK SE & Co. KG
Device Count	2
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
Labeled No 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	04035479138516 [Primary]
GS1	04035479158101 [Unit of Use]

NVY	Permanent defibrillator electrodes

Steralize Prior To Use	false
Device Is Sterile	true

04035479138523	401298
04035479138516	401297