DEVICE: nGEN Generator (10846835018080)

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Device Record History
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Device Identifier (DI) Information
nGEN Generator
D138402
In Commercial Distribution
D138402
Biosense Webster Inc
10846835018080
GS1

1
020163218 *Terms of Use
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?
60784 Cardiac radio-frequency ablation system generator
An electrically-powered, noninvasive device intended to be used to generate radio-frequency energy to create ablative lesions in the cardiac tissue of a beating heart in the treatment of cardiac arrhythmias. The generator includes controls and may include electrocardiograph (ECG) interfacing/monitoring functionality. It may be intended to be used with a radio-frequency catheter for endocardial ablation and/or an epicardial probe for epicardial ablation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LPB Cardiac ablation percutaneous catheter
OAE Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P010068 067
P030031 122
P040036 084
P950005 082
P990025 067
P990071 051
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep out of direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7bf94063-b51e-42ac-80ea-c024d889d3e1
January 16, 2025
2
August 18, 2022
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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

[?]
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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