3Way Foley Balloon Catheter

Primary DI
08800109201603
Brand
3Way Foley Balloon Catheter
Company
AP MDS Co., Ltd.
Model
APO-FC-318
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
18800109201600PackageGS110In Commercial Distribution
28800109201607PackageGS1100In Commercial Distribution
08800109201603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880010920160018800109201600
2880010920160728800109201607
08800109201603088001092016038800109201603

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

Contacts#

Phone, Email table
PhoneEmail
9252623218kcheungmd@gmail.com

Regulatory Flags#

DUNS number
694741911
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
088001092015352Way Foley Balloon CatheterAPO-FC-0112022-02-10
088001092015422Way Foley Balloon CatheterAPO-FC-0102022-02-10
088001092015592Way Foley Balloon CatheterAPO-FC-0092022-02-11
088001092015662Way Foley Balloon CatheterAPO-FC-0082022-02-11
088001092015732Way Foley Balloon CatheterAPO-FC-0072022-02-11
088001092015803Way Foley Balloon CatheterAPO-FC-3142022-02-11
088001092015973Way Foley Balloon CatheterAPO-FC-3162022-02-11
088001092016103Way Foley Balloon CatheterAPO-FC-3202022-02-11
088001092016273Way Foley Balloon CatheterAPO-FC-3222022-02-11
088001092016343Way Foley Balloon CatheterAPO-FC-3242022-02-11
08800109203300Silicone BandageABST-1-12024-04-19
08800109203317Silicone BandageABST-1-22024-04-19
08800109203324Silicone BandageABST-1-32024-04-19
08800109203331Silicone BandageABST-2-12024-04-19
08800109203348Silicone BandageABST-2-22024-04-19
08800109203355Silicone BandageABST-2-32024-04-19
08800109203362Silicone BandageABST-4-12024-04-19
08800109203379Silicone BandageABST-4-22024-04-19
08800109203386Silicone BandageABST-4-222024-04-19
08800109203393Silicone BandageABST-4-32024-04-19

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