DEVICE: Itrevia 7 HF-T (04035479129309)
Device Identifier (DI) Information
Itrevia 7 HF-T
393014
Not in Commercial Distribution
393014
BIOTRONIK SE & Co. KG
393014
Not in Commercial Distribution
393014
BIOTRONIK SE & Co. KG
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47270 | Cardiac resynchronization therapy implantable defibrillator |
An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 41 and 113 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
29c82e55-db32-462e-8d48-61fcd3fcb4c5
February 05, 2021
6
February 18, 2015
February 05, 2021
6
February 18, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(888)345-0374
jon.brumbaugh@biotronik.com
jon.brumbaugh@biotronik.com