DEVICE: Silicone 2-way Foley Balloon Catheter (Integrated Balloon) (04710961936510)

Device Identifier (DI) Information

Silicone 2-way Foley Balloon Catheter (Integrated Balloon)
4822-0512
In Commercial Distribution

FORTUNE MEDICAL INSTRUMENT CORP.
04710961936510
GS1

10
656763489 *Terms of Use
No description.
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Device Characteristics

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

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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?
34917 Indwelling urethral drainage balloon catheter, non-antimicrobial
A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed 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). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.
Active false
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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
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
No Device Sizes
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Device Record Status

5db03124-4604-473c-bf86-1a31c69ca4e3
December 04, 2020
9
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: 14710961936517 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
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Customer Contact

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No Customer Contact currently defined
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