DEVICE: Livewire™ (05414734202664)

Device Identifier (DI) Information

Livewire™
401938
In Commercial Distribution
401938
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
05414734202664
GS1

1
040960379 *Terms of Use
Steerable Electrophysiology Catheter
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Device Characteristics

Labeling does not contain MRI Safety Information
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46355 Cardiac mapping catheter, percutaneous, single-use
A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DRA CATHETER, STEERABLE
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DARK, DRY PLACE AWAY FROM RADIOACTIVE SOURCES.
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 5 French
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Device Record Status

10989443-9fbd-4c10-91f5-43d055dc6f72
November 01, 2023
4
February 06, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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