Pamira 428772

GUDID 04035479156480

Endocardial defibrillation lead

Primary Device ID	04035479156480
NIH Device Record Key	9263fbc8-9021-41e1-b331-fe5898c09fb9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Pamira
Version Model Number	SD 65/16
Catalog Number	428772
Company DUNS	315620229
Company Name	BIOTRONIK SE & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	false
Serial Number	true
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 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit
Storage Environment Temperature	Between 0 and 77 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	04035479156480 [Primary]

NVY	Permanent defibrillator electrodes

Steralize Prior To Use	false
Device Is Sterile	true

Mark Image Registration \| Serial	Company Trademark Application Date
PAMIRA 97033308 not registered Live/Pending	BIOTRONIK SE & Co. KG 2021-09-17