Pamira 428773

GUDID 04035479156497

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead
Primary Device ID04035479156497
NIH Device Record Keye717c6d1-5638-4dac-b141-26ae78deeb8e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePamira
Version Model NumberSD 65/18
Catalog Number428773
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479156497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVYPermanent defibrillator electrodes

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-08
Device Publish Date2023-01-24

On-Brand Devices [Pamira]

04035479156527S DX 65/17
04035479156510S DX 65/15
04035479156503SD 75/18
04035479156497SD 65/18
04035479156480SD 65/16
04035479156473SD 60/16
04035479156466S 75
04035479156459S 65
04035479156442S 60

Trademark Results [Pamira]

Mark Image

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

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