DEVICE: TRUPULSE™ Generator (10846835025248)

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Device Record History
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Device Identifier (DI) Information
TRUPULSE™ Generator
D141702
In Commercial Distribution
D141702
Biosense Webster Inc
10846835025248
GS1

1
020163218 *Terms of Use
TRUPULSE Generator
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
65067 Cardiac irreversible electroporation system generator
A cardiac-dedicated mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation (a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death) for the selective nonthermal ablation of cardiac tissues. It includes controls (e.g., foot-switch), user interface, and is designed to connect to appropriate cardiac mapping equipment and catheter (not included).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QZI Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P240006 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Do not stack
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Temperature: between -40 and 60 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
3d4560c5-e22a-44cf-b32f-0dc5027f46ad
December 19, 2024
1
December 11, 2024
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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

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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)729-9010
RA-BWIUS-Complaints@its.jnj.com
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