DEVICE: Corox (04035479112165)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
Yes | |
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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60910 | Coronary venous pacing lead |
An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted cardiac resynchronization therapy (CRT) pulse generator to the left ventricle of the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is introduced into a cardiac vein through transvenous approach via the coronary sinus. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OJX | Drug eluting permanent left ventricular (lv) pacemaker electrode |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P070008 | 015 |
P070008 | 070 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 77 Degrees Fahrenheit |
Special Storage Condition, Specify: Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Max. Diameter: 1.95 mm |
Device Size Text, specify: Length: 77 cm |
Device Record Status
7872f057-48ad-4dd5-82b5-95eaf2ed8905
February 05, 2021
4
August 08, 2014
February 05, 2021
4
August 08, 2014
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