DEVICE: NA (00643169950146)

Device Identifier (DI) Information

NA
203CX
In Commercial Distribution

MEDTRONIC, INC.
00643169950146
GS1

1
006261481 *Terms of Use
CABLE 203CX COAXIAL UMBILICAL ROHS
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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?
56300 Liquid nitrous oxide coaxial tubing
A sterile, double lumen (coaxial) tube in a straight or spiral design used to conduct liquid nitrous oxide (N2O) from an N2O cylinder to a medical device to act as a refrigerant typically for cryotherapy, e.g., cardiac cryoablation. It is typically constructed of polymeric material and may be available in various lengths. The coaxial design (inner and outer tubing) facilitates the removal of the exhaust N2O gases. 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 080
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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: Keep dry
Special Storage Condition, Specify: Fragile: handle with care
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
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3089ee82-678d-4711-a5ee-0c0a88a39b98
July 06, 2018
3
April 02, 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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