DEVICE: Silicone 2-way Foley Catheter Tiemann Tip (Standard Balloon) (04710961933342)

Device Identifier (DI) Information

Silicone 2-way Foley Catheter Tiemann Tip (Standard Balloon)
1856-0212
In Commercial Distribution

FORTUNE MEDICAL INSTRUMENT CORP.
04710961933342
GS1

10
656763489 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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 at its distal tip intended to be inserted through the urethra and retained in the urinary bladder to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Commonly known as a Foley catheter, it is intended to be introduced by a healthcare professional. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K980919 000
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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 Record Status

a695c241-e831-46d6-bd15-5a787de7a44d
September 24, 2018
6
March 11, 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: 14710961933349 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
No
Yes
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Customer Contact

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No Customer Contact currently defined
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