2Way Foley Balloon Catheter

GUDID 08800109200033

This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifold part and a Shaft parts. The Manifold Parts is equipped with a non-return valve for inflate the balloon and a band to fix the non-return valve and to identify the catheter’s size by color. The Shaft parts has an x-ray opaque line for check to position and balloon for located the catheter in the bladder, a drainage eye for urine drainage, and a rounded tip for easy insertion of the shaft. The proposed device is supplied in French size ranging from 12 to 24. It is available in 337(±15) and 345(±15) mm length with various balloon sizes. The devices are applied for adults only.

APOLLON Co., Ltd.

Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial
Primary Device ID08800109200033
NIH Device Record Key143c38c9-50ad-4d13-aaed-0cc136e9d022
Commercial Distribution StatusIn Commercial Distribution
Brand Name2Way Foley Balloon Catheter
Version Model NumberAPO-FC-013
Company DUNS695407034
Company NameAPOLLON Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com
Phone9252623218
Emailkcheungmd@gmail.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 40 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108800109200033 [Primary]
GS118800109200030 [Package]
Package: [10 Units]
In Commercial Distribution
GS128800109200037 [Package]
Contains: 18800109200030
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZLCatheter, Retention Type, Balloon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-31
Device Publish Date2022-01-21

On-Brand Devices [2Way Foley Balloon Catheter]

08800109200033This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
08800109201511This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
08800109201528This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
18800109201549This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
18800109201532This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
18800109201570This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
18800109201563This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
18800109201556This product is a Foley Balloon Catheter commonly used in urology. It is consisting of a Manifol
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.