DEVICE: ETHICON (10705031050891)
Device Identifier (DI) Information
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45966 | Transthoracic pacing lead |
A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor between the heart and an external temporary pacing/defibrillation device used to treat postoperative cardiac arrhythmias/cardiac arrests. The electrode end is attached to the myocardium. The other end initially is typically attached to a removable needle used to perforate the chest wall from the inside out, after which it is connected to a pulse generator, typically via an adaptor. This device is only used for temporary pacing of the heart and is removed once the patient is stable. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LDF | ELECTRODE, PACEMAKER, TEMPORARY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K173923 | 000 |
K980503 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f9062c56-adb6-4164-aebb-f8b0e9f8ebd3
January 16, 2023
4
September 01, 2015
January 16, 2023
4
September 01, 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 |
---|---|---|---|---|---|
30705031050895 | 12 | 10705031050891 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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(877)384-4266
xxx@xxx.xxx
xxx@xxx.xxx