DEVICE: Freezor® Xtra (00643169672475)

Device Identifier (DI) Information

Freezor® Xtra
227F3
In Commercial Distribution

MEDTRONIC, INC.
00643169672475
GS1

1
006261481 *Terms of Use
CATHETER 227F3 FREEZOR XTRA3 MED7F
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LPB Cardiac ablation percutaneous catheter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P020045 073
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Sterilization

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

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
Length: 108.0 Centimeter
Device Size Text, specify: catheter tip length 6mm
Catheter Gauge: 7.0 French
Device Size Text, specify: catheter curve 55mm
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Device Record Status

7f47f381-1290-4942-8233-3d82a61f5bd2
July 06, 2018
3
February 16, 2017
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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

[?]
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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