CELERITY 382972

GUDID 04035479143275

BIOTRONIK SE & Co. KG

Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead Coronary venous pacing lead
Primary Device ID04035479143275
NIH Device Record Key87dc6122-938d-48d4-9921-e7ced0852874
Commercial Distribution StatusIn Commercial Distribution
Brand NameCELERITY
Version Model NumberPilot 85
Catalog Number382972
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
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
Device Size Text, specify0
Device Size Text, specify0

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
GS104035479143275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OJXDrug eluting permanent left ventricular (lv) pacemaker electrode

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 [CELERITY]

04035479143282Pilot 75
04035479143275Pilot 85
040354791432682D 85
040354791432512D 75
040354791432443D 75
040354791432373D 85

Trademark Results [CELERITY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CELERITY
CELERITY
98323013 not registered Live/Pending
Celerity Technology Inc
2023-12-20
CELERITY
CELERITY
97913251 not registered Live/Pending
Amphenol Corporation
2023-04-28
CELERITY
CELERITY
97040707 not registered Live/Pending
Adcomm MDU Services, LLC
2021-09-22
CELERITY
CELERITY
90004645 not registered Live/Pending
AS America, Inc.
2020-06-16
CELERITY
CELERITY
88810892 not registered Live/Pending
Blumberg Excelsior, Inc.
2020-02-26
CELERITY
CELERITY
87571613 5608127 Live/Registered
STERIS CORPORATION
2017-08-16
CELERITY
CELERITY
86420814 not registered Live/Pending
Hydrogenics Corporation
2014-10-10
CELERITY
CELERITY
86368787 not registered Dead/Abandoned
eMath.com, Inc.
2014-08-16
CELERITY
CELERITY
85431952 4664067 Live/Registered
Medical Components, Inc.
2011-09-26
CELERITY
CELERITY
79177221 not registered Live/Pending
Celerity Systems Limited
2015-10-21
CELERITY
CELERITY
78633315 not registered Dead/Abandoned
InfiMed, Inc.
2005-05-19
CELERITY
CELERITY
78613655 not registered Dead/Abandoned
Cool Amphibious Manufacturers International, LLC
2005-04-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.