DEVICE: Disposable Silicone Foley Catheter (06938634484146)
Device Identifier (DI) Information
Disposable Silicone Foley Catheter
Two-way 6Fr
In Commercial Distribution
FX-020631
Guangdong Baihe Medical Technology Co., Ltd.
Two-way 6Fr
In Commercial Distribution
FX-020631
Guangdong Baihe Medical Technology Co., Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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32031 | Indwelling urethral catheterization kit, adult |
A collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.
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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EZL | Catheter, Retention Type, Balloon |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K130908 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
82cbd044-ad95-4742-a93d-eb99deb45a21
June 20, 2024
11
September 20, 2016
June 20, 2024
11
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
26938634484140 | 20 | 16938634484143 | In Commercial Distribution | ||
16938634484143 | 10 | 06938634484146 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined