DEVICE: Disposable Silicone Foley Catheter Three-way 20Fr (06938634494916)

Device Identifier (DI) Information

Disposable Silicone Foley Catheter Three-way 20Fr
110-FX-032040
In Commercial Distribution

Guangdong Baihe Medical Technology Co., Ltd.
06938634494916
GS1

1
547055364 *Terms of Use
No description.
CLOSE

Device Characteristics

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

GMDN

[?]

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EZL Catheter, Retention Type, Balloon
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130908 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

9cefa688-c0e3-436d-9a2c-c8c2ce6cba99
September 24, 2018
6
September 20, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
26938634494910 200 16938634494913 In Commercial Distribution
16938634494913 10 06938634494916 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE