DEVICE: Silicone 2-way Foley Balloon Catheter Tiemann Tip (Integrated Balloon) (04710961937104)

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Device Identifier (DI) Information

Silicone 2-way Foley Balloon Catheter Tiemann Tip (Integrated Balloon)
4856-0216

FORTUNE MEDICAL INSTRUMENT CORP.
04710961937104
GS1
10
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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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
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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
No Device Sizes
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Device Status

In Commercial Distribution
March 10, 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
No Package DIs found
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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: 14710961937101 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
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Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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