FDA.reportPublic FDA data

Latex Foley Catheter

Primary DI
16944932762012
Brand
Latex Foley Catheter
Company
Well Lead Medical Co.,Ltd
Model
F01A041406
Device description
2 way Female 14Fr5-15ml
Published
2024-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MJCCatheter, Urological (Antimicrobial) And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJCCatheter, Urological (Antimicrobial) And AccessoriesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082815000WELL LEAD SILICONE AND LATEX FOLEY CATHETERSWell Lead Medical Instruments2008-10-08EZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16944932762012PackageGS110In Commercial Distribution
26944932762019PackageGS150In Commercial Distribution
06944932762015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694493276201216944932762012
2694493276201926944932762019
06944932762015069449327620156944932762015

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544811862
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
06925816673962Wellead Hydrophilic Intermittent Catheter F01L0308302026-04-03
06925816673979Wellead Hydrophilic Intermittent Catheter F01L0310302026-04-03
06925816673986Wellead Hydrophilic Intermittent Catheter F01L0312302026-04-03
06925816673993Wellead Hydrophilic Intermittent Catheter F01L0314302026-04-03
06925816674006Wellead Hydrophilic Intermittent Catheter F01L0316302026-04-03
06925816674013Wellead Hydrophilic Intermittent Catheter F01L0318302026-04-03
06925816674020Wellead Hydrophilic Intermittent Catheter F01L0208202026-04-03
06925816674037Wellead Hydrophilic Intermittent Catheter F01L0210202026-04-03
06925816674044Wellead Hydrophilic Intermittent Catheter F01L0212202026-04-03
06925816674051Wellead Hydrophilic Intermittent Catheter F01L0214202026-04-03
06925816674068Wellead Hydrophilic Intermittent Catheter F01L0216202026-04-03
06925816674075Wellead Hydrophilic Intermittent Catheter F01L0218202026-04-03
06925816674082Wellead Hydrophilic Intermittent Catheter F01L0410302026-04-03
06925816674099Wellead Hydrophilic Intermittent Catheter F01L0412302026-04-03
06925816674105Wellead Hydrophilic Intermittent Catheter F01L0414302026-04-03
06925816674112Wellead Hydrophilic Intermittent Catheter F01L0416302026-04-03
06925816674129Wellead Hydrophilic Intermittent Catheter F01L0418302026-04-03
06925816674136Wellead Hydrophilic Intermittent Catheter F01L0108102026-04-03
06925816674143Wellead Hydrophilic Intermittent Catheter F01L0110102026-04-03
06925816674150Wellead Hydrophilic Intermittent Catheter F01L0112102026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00801741017421Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741017438Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741017445Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741017452Bardex® I.C. Foley CatheterC. R. Bard, Inc.MJC2016-12-19
00801741039775Bardex® I.C. Temperature Sensing Foley CatheterC. R. Bard, Inc.MJC2016-08-06
00801741039782Bardex® I.C. Temperature Sensing Foley CatheterC. R. Bard, Inc.MJC2016-08-06
00801741039799Bardex® I.C. Temperature-Sensing Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039805Bardex® I.C. Temperature-Sensing Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039843Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039850Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039867Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley CatheterC. R. Bard, Inc.MJC2016-07-28
00801741039973Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741039980Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741039997Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040009Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040016Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040023Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040030Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040047Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040054Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040061Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040078Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040085Bardex® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040122Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040139Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741040146Lubri-Sil® I.C. Complete Care® Temperature-Sensing Urine Meter Foley TrayC. R. Bard, Inc.MJC2016-07-28
00801741019364Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26
00801741019371Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26
00801741019388Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26
00801741019395Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.MJC2016-07-26