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
Catalog Number:
Company Name: Guangdong Baihe Medical Technology Co., Ltd.

Primary DI Number: 06938634494916
Issuing Agency: GS1
Device Count: 1

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 on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as an indwelling therapeutic device for urinary incontinence (e.g., following a urological surgery procedure), or as a means to void for non-ambulatory patients. It may have a bent tip (coude) to facilitate negotiation of the prostatic curve. It is inserted by trained staff and is commonly known as a Foley catheter. Insertion is typically through the urethra but it may be accomplished by suprapubic placement or by nephrostomy. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Indwelling urethral drainage catheter

A sterile, flexible tube with an inflatable balloon on its distal tip for retention in the urinary bladder, after its insertion through the urethra, where it functions as an indwelling therapeutic device for urinary incontinence (e.g., following a urological surgery procedure), or as a means to void for non-ambulatory patients. It may have a bent tip (coude) to facilitate negotiation of the prostatic curve. It is inserted by trained staff and is commonly known as a Foley catheter. Insertion is typically through the urethra but it may be accomplished by suprapubic placement or by nephrostomy. This is a single-use device.

FDA Product Code

[?]

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

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 20, 2016
Commercial Distribution End Date:

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

Secondary DI

[?]

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

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