DEVICE: Freezor® Xtra (00643169672475)
Device Identifier (DI) Information
Freezor® Xtra
227F3
In Commercial Distribution
MEDTRONIC, INC.
227F3
In Commercial Distribution
MEDTRONIC, INC.
CATHETER 227F3 FREEZOR XTRA3 MED7F
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? |
---|---|---|---|---|
60720 | Cardiac cryosurgical system catheter |
A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). 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 [?] |
---|---|
P020045 | 073 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Fragile handle with care |
Special Storage Condition, Specify: Keep dry |
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between -35 and 58 Degrees Celsius |
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 108.0 Centimeter |
Device Size Text, specify: catheter tip length 6mm |
Catheter Gauge: 7.0 French |
Device Size Text, specify: catheter curve 55mm |
Device Record Status
7f47f381-1290-4942-8233-3d82a61f5bd2
July 06, 2018
3
February 16, 2017
July 06, 2018
3
February 16, 2017
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