DEVICE: RF Enhancr™ II (00763000227777)
Device Identifier (DI) Information
RF Enhancr™ II
31744523
In Commercial Distribution
MEDTRONIC, INC.
31744523
In Commercial Distribution
MEDTRONIC, INC.
CATH 31744523 RF ENHANCR II W/O CE
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61785 | Cardiac radio-frequency ablation system catheter |
A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPB | Cardiac ablation percutaneous catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P930029 | 065 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between -31 and 140 Degrees Fahrenheit |
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit |
Special Storage Condition, Specify: Keep Dry |
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Catheter distal electrode size 4 mm |
Device Size Text, specify: Electrode spacing 2.5.2 mm |
Device Size Text, specify: Catheter usable length 110 cm |
Device Size Text, specify: Catheter deflectable tip length 45 mm |
Device Size Text, specify: Catheter size 2.3mm (7 Fr) |
Device Record Status
c60a87fa-3833-49c7-98b7-20983b7ae49e
July 31, 2020
1
July 23, 2020
July 31, 2020
1
July 23, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com