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

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Silicone Foley Catheter Three-way 20Fr
Version or Model: 110-FX-032040
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangdong Baihe Medical Technology Co., Ltd.

Primary DI Number: 06938634494916
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 547055364 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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.

FDA Product Code

[?]

Product Code	Product Code Name
EZL	Catheter, Retention Type, Balloon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130908	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9cefa688-c0e3-436d-9a2c-c8c2ce6cba99
Public Version Date: September 24, 2018
Public Version Number: 6
DI Record Publish Date: September 20, 2016