VOLTA 384075

GUDID 04035479143374

BIOTRONIK SE & Co. KG

Endocardial defibrillation lead
Primary Device ID04035479143374
NIH Device Record Key425814cc-d71a-4ff2-8b2f-c430a1b5e8b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOLTA
Version Model Number1CR 65
Catalog Number384075
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store at temperatures up to 77°F; excursions permitted from 41°F to 131°F.
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479143374 [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 Number4
Public Version Date2021-02-05
Device Publish Date2014-08-19

On-Brand Devices [VOLTA]

040354791434352CT 65/18
040354791434282CR 75/18
040354791434112CR 65/18
040354791434042CR 65/16
040354791433982CR 60/16
040354791433811CR 75
040354791433741CR 65
040354791433671CR 60
040354791431452CT 65/16
040354791431381CT 65
040354791431212CT 75/18

Trademark Results [VOLTA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VOLTA
VOLTA
98645932 not registered Live/Pending
Volta Labs, Inc.
2024-07-12
VOLTA
VOLTA
98635580 not registered Live/Pending
Garcia, Emilio J
2024-07-06
VOLTA
VOLTA
98594652 not registered Live/Pending
Hydril USA Distribution LLC
2024-06-11
VOLTA
VOLTA
98567241 not registered Live/Pending
Volta Talent Strategies LLC
2024-05-24
VOLTA
VOLTA
98562112 not registered Live/Pending
Tech Quick Repair Inc
2024-05-21
VOLTA
VOLTA
98533760 not registered Live/Pending
Lumencor, Inc.
2024-05-03
VOLTA
VOLTA
98474880 not registered Live/Pending
Preston, Torri R
2024-03-29
VOLTA
VOLTA
98474880 not registered Live/Pending
Reed, Gordon F
2024-03-29
VOLTA
VOLTA
98438700 not registered Live/Pending
NuKey, Inc.
2024-03-07
VOLTA
VOLTA
98124424 not registered Live/Pending
Spark Biomedical, Inc.
2023-08-09
VOLTA
VOLTA
97779812 not registered Live/Pending
Io Financial Inc.
2023-02-03
VOLTA
VOLTA
97768107 not registered Live/Pending
VOLTA ROBOTS S.R.L.
2023-01-25

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