FDA.reportPublic FDA data

Disposable Silicone Foley Catheter Two-way 24Fr

Primary DI
06938634494879
Brand
Disposable Silicone Foley Catheter Two-way 24Fr
Company
Guangdong Baihe Medical Technology Co., Ltd.
Model
040-FX-022440
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
16938634494876PackageGS110In Commercial Distribution
26938634494873PackageGS1200In Commercial Distribution
06938634494879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693863449487616938634494876
2693863449487326938634494873
06938634494879069386344948796938634494879

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.

Regulatory Flags#

DUNS number
547055364
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08886483507487Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
08886483507494Silicone Foley CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.EZL2026-05-04
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