FDA.reportPublic FDA data

Disposable Silicone Foley Catheter Two-way 12Fr

Primary DI
26938634494774
Brand
Disposable Silicone Foley Catheter Two-way 12Fr
Company
Guangdong Baihe Medical Technology Co., Ltd.
Model
040-FX-021240
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K130908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130908000DISPOSABLE SILICONE FOLEY CATHETERGuangdong Baihe Medical Technology Co., Ltd.2013-10-03EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938634494777PackageGS110In Commercial Distribution
26938634494774PackageGS1200In Commercial Distribution
06938634494770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693863449477716938634494777
2693863449477426938634494774
06938634494770069386344947706938634494770

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, 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, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
547055364
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
06938634454309Disposable Hemodialysis Access Catheter Set Single Lumen8F*10cmFH-18132016-09-22
06938634454422Disposable Hemodialysis Access Catheter Set Single Lumen7F*10cmFH-17132016-09-22
06938634460133ABLE CENTRAL VENOUS CATHETERTriple Lumen 7F*30cmFV-37282016-09-22
06938634460171ABLE CENTRAL VENOUS CATHETERTriple Lumen 7F*13cmFC-37242016-09-22
06938634461857ABLE CENTRAL VENOUS CATHETERDouble Lumen 5F*10cmFC-25232016-09-22
06938634463035ABLE CENTRAL VENOUS CATHETERDouble Lumen 7F*10cmFV-27232016-09-20
06938634463196ABLE CENTRAL VENOUS CATHETERSingle Lumen 16G*10cmFV-15232016-09-22
06938634469624Disposable Hemodialysis Access Catheter Set Double Lumen 14F*20cmFR-24162016-09-20
06938634469662Disposable Hemodialysis Access Catheter Set Double Lumen14F*16cmFR-24152016-09-20
06938634469709Disposable Hemodialysis Access Catheter Set Double Lumen 14F*15cmFR-2419152016-09-20
06938634469815Disposable Hemodialysis Access Catheter Set Double Lumen12F*20cmFR-22562016-09-22
06938634469891Disposable Hemodialysis Access Catheter Set Double Lumen12F*16cmFR-22552016-09-22
06938634469938Disposable Hemodialysis Access Catheter Set Double Lumen12F*15cmFR-2259152016-09-22
06938634469976Disposable Hemodialysis Access Catheter Set Double Lumen12F*13cmFR-22542016-09-22
06938634469983Disposable Hemodialysis Access Catheter Set Double Lumen12F*13cmFR-22142016-09-20
06938634470491Disposable Hemodialysis Access Catheter Set Double Lumen 11.5F*20cmFR-21162016-09-22
06938634470514Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*20cmFH-21162016-09-22
06938634470583Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cmFH-21552016-09-22
06938634470590Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*16cmFH-21152016-09-22
06938634470613Disposable Hemodialysis Access Catheter Set Double Lumen11.5F*15cmFR-2119152016-09-22

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
08886483507494Silicone 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