FDA.reportPublic FDA data

Silicone Foley Catheter

Primary DI
08886483507494
Brand
Silicone Foley Catheter
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
FC318S
Catalog number
DC-0001-015
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K182463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182463000Silicone Foley CatheterBiosensors International Pte, Ltd.2019-11-06EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886483507494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886483507494088864835074948886483507494

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
Special Storage Condition, Specify00The product should be stored in a ventilated, dry, non-corrosive room.

Contacts#

Phone, Email table
PhoneEmail
+6568592341ra-bpi@bioptimalg.com

Regulatory Flags#

DUNS number
595182247
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886483551640Thermodilution Catheter and AccessoriesTD1755HD21-000153-502026-05-20
08886483551657Thermodilution Catheter and AccessoriesTD2755NDF21-000202-452026-05-20
08886483551664Safewedge(TM) Relief Valve DeviceSafetywedge21-000212-012026-05-20
08886483500174Thermodilution Catheter and AccessoriesTD2604NXF21-000009-582026-05-04
08886483500181Thermodilution Catheter and AccessoriesTD2604NDXF21-000009-592026-05-04
08886483500372Thermodilution Catheter and AccessoriesTD2504NXF21-000046-432026-05-04
08886483500389Thermodilution Catheter and AccessoriesTD2504NDXF21-000046-442026-05-04
08886483501508Thermodilution Catheter and AccessoriesTD2704NDF21-000201-162026-05-04
08886483501515Thermodilution Catheter and AccessoriesTD2704NCXF21-000201-172026-05-04
08886483501546Thermodilution Catheter and AccessoriesTD2755NX21-000202-002026-05-04
08886483501553Thermodilution Catheter and AccessoriesTD2755NDF21-000202-012026-05-04
08886483501577Thermodilution Catheter and AccessoriesTD2755NDX21-000202-032026-05-04
08886483501584Thermodilution Catheter and AccessoriesTD2755NDPXF21-000202-042026-05-04
08886483502390BIOTRANS™ Pressure Monitoring KitsBTR4812-322-000813-232026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsEXTENSION TUBING SET22-000895-962026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitAT W/O IFU(BNS)22-000940-022026-05-04
08886483504455Embolectomy CatheterEL144023-000006-152026-05-04
08886483504486Embolectomy CatheterEL158023-000006-182026-05-04
08886483504516Embolectomy CatheterEL154023-000006-212026-05-04
08886483507005BIOTRANS™ Reusable Sensor Base and Monitor Adapter CablesBT-201BL-0003-0182026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483507470Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
10192253068221DoverCardinal Health 200, LLCEZL2026-01-15
10192253068238DoverCardinal Health 200, LLCEZL2026-01-15
10192253067651DoverCardinal Health 200, LLCEZL2025-04-14
10192253067668DoverCardinal Health 200, LLCEZL2025-04-14
10192253067675DoverCardinal Health 200, LLCEZL2025-04-14
10192253067682DoverCardinal Health 200, LLCEZL2025-04-14
10192253031423DoverCardinal Health 200, LLCEZL2025-01-15
10192253031409DoverCardinal Health 200, LLCEZL2025-01-14
10192253031416DoverCardinal Health 200, LLCEZL2025-01-14
10192253038897DoverCardinal Health 200, LLCEZL2025-01-14
10192253031140DoverCardinal Health 200, LLCEZL2024-12-20
10192253031164DoverCardinal Health 200, LLCEZL2024-12-20
10192253066203DoverCardinal Health 200, LLCEZL2024-09-04
10192253066210DoverCardinal Health 200, LLCEZL2024-09-04
10192253066227DoverCardinal Health 200, LLCEZL2024-09-04
10192253066234DoverCardinal Health 200, LLCEZL2024-09-04
10192253066241DoverCardinal Health 200, LLCEZL2024-09-04
10192253066258DoverCardinal Health 200, LLCEZL2024-09-04
10192253066265DoverCardinal Health 200, LLCEZL2024-09-04
10192253066272DoverCardinal Health 200, LLCEZL2024-09-04
10192253066289DoverCardinal Health 200, LLCEZL2024-09-04
10192253066296DoverCardinal Health 200, LLCEZL2024-09-04
10192253066302DoverCardinal Health 200, LLCEZL2024-09-04
10192253066319DoverCardinal Health 200, LLCEZL2024-09-04
10192253066326DoverCardinal Health 200, LLCEZL2024-09-04
10192253066333DoverCardinal Health 200, LLCEZL2024-09-04
10192253066340DoverCardinal Health 200, LLCEZL2024-09-04
10192253066357DoverCardinal Health 200, LLCEZL2024-09-04