DEVICE: RUSCH (04026704307982)

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Device Identifier (DI) Information

RUSCH
IPN050129
170003100
TELEFLEX INCORPORATED
04026704307982
GS1
1
100% Silicone Foley Balloon Catheter (2 Way)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Indwelling urethral drainage catheter A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as an indwelling therapeutic device for urinary incontinence (e.g., following a urological surgery procedure), or as a means to void for non-ambulatory patients. It may have a bent tip (coude) to facilitate negotiation of the prostatic curve. It is inserted by trained staff and is commonly known as a Foley catheter. Insertion is typically through the urethra but it may be accomplished by suprapubic placement or by nephrostomy. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EZL CATHETER, RETENTION TYPE, BALLOON
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 3.3 Millimeter
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Device Status

In Commercial Distribution
September 16, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
24026704307986 10 04026704307982 In Commercial Distribution Box
44026704307980 10 24026704307986 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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