Intica 7 HF-T 404627

GUDID 04035479142148

BIOTRONIK SE & Co. KG

Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator Cardiac resynchronization therapy implantable defibrillator
Primary Device ID04035479142148
NIH Device Record Keyc71d21e5-7fa4-4eca-9290-6e46cda6df8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntica 7 HF-T
Version Model Number404627
Catalog Number404627
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 Productfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479142148 [Primary]

FDA Product Code

NIKDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-28
Device Publish Date2018-12-13

Devices Manufactured by BIOTRONIK SE & Co. KG

04035479184575 - BIOTRONIK2024-02-28
04035479116644 - Selectra2024-01-25
04035479184285 - NEO2023-12-25
04035479184292 - PSW2023-12-25
04035479185510 - Renamic Neo NEOexpress2023-12-25
04035479183264 - Home Monitoring Service Center2023-10-23
04035479100650 - S 60-C2023-10-09
04035479011864 - S 75-A2023-10-06

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