DEVICE: Response™ (05414734200950)

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Device Identifier (DI) Information

Response™
JSN™
401360
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
05414734200950
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cardiac mapping/radio-frequency ablation catheter, single-use A sterile, flexible, steerable catheter intended to be used as part of a cardiac mapping system and/or a radio-frequency cardiac ablation system to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping, and/or to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart, in the evaluation/treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DRF CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Sterilization

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

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

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Size Type Text
Catheter Gauge: 5 French
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Device Status

In Commercial Distribution
May 12, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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