DEVICE: Protego DF-1 (04035479151065)
Device Identifier (DI) Information
Protego DF-1
SD 65/18
Not in Commercial Distribution
414016
BIOTRONIK SE & Co. KG
SD 65/18
Not in Commercial Distribution
414016
BIOTRONIK SE & Co. KG
No description.
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? |
---|---|---|---|---|
35853 | Endocardial defibrillation lead |
An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. 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 |
---|---|
NVY | Permanent defibrillator electrodes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P980023 | 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 deg F; excursions permitted from 41 deg F to 131 deg F |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Length: 65 cm |
Device Size Text, specify: Distance tip/SVC: 180 mm |
Device Record Status
33e1b36c-86ac-40ff-bbfd-91395f06c3a2
October 06, 2022
5
December 03, 2015
October 06, 2022
5
December 03, 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 |
---|---|---|---|---|---|
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