3Way Foley Balloon Catheter

Primary DI
18800109201631
Brand
3Way Foley Balloon Catheter
Company
APOLLON Co., Ltd.
Model
APO-FC-324
Device description
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.
Published
2022-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZLCatheter, Retention Type, Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZLCatheter, Retention Type, BalloonGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201776000Foley Balloon Catheter for UrologyApollon Co., Ltd.2020-12-30EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800109201631PackageGS110In Commercial Distribution
28800109201638PackageGS1100In Commercial Distribution
08800109201634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010920163118800109201631
2880010920163828800109201638
08800109201634088001092016348800109201634

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage balloon catheter, non-antimicrobialA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9252623218kcheungmd@gmail.com

Regulatory Flags#

DUNS number
695407034
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
188001092015562Way Foley Balloon CatheterAPO-FC-0092022-02-11
188001092015632Way Foley Balloon CatheterAPO-FC-0082022-02-11
188001092015702Way Foley Balloon CatheterAPO-FC-0072022-02-11
188001092015873Way Foley Balloon CatheterAPO-FC-3142022-02-11
188001092015943Way Foley Balloon CatheterAPO-FC-3162022-02-11
188001092016003Way Foley Balloon CatheterAPO-FC-3182022-02-11
188001092016173Way Foley Balloon CatheterAPO-FC-3202022-02-11
188001092016243Way Foley Balloon CatheterAPO-FC-3222022-02-11
188001092015322Way Foley Balloon CatheterAPO-FC-0112022-02-10
188001092015492Way Foley Balloon CatheterAPO-FC-0102022-02-10
088001092000332Way Foley Balloon CatheterAPO-FC-0132022-01-21

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