DEVICE: RUSCH (04026704302642)

Device Identifier (DI) Information

RUSCH
IPN052930
In Commercial Distribution
664130-000220
TELEFLEX INCORPORATED
04026704302642
GS1

1
002348191 *Terms of Use
SoftSimplastic 3 Way Foley Couvelaire Tip Catheter
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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?
34930 Single-administration urethral drainage/irrigation catheter
A sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EZL CATHETER, RETENTION TYPE, BALLOON
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 7.3 Millimeter
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Device Record Status

c9e1d8b4-f0b6-4bd9-9742-68210328d721
August 21, 2024
2
November 13, 2020
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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
24026704302646 10 04026704302642 2024-08-21 Not in Commercial Distribution Box
44026704302640 12 24026704302646 2024-08-21 Not in Commercial Distribution Case
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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