Latex Foley Catheter

GUDID 16925816600095

2 way Female 12Fr20ml

Well Lead Medical Co.,Ltd

Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 16925816600095
• NIH Device Record Key: 60548a89-317e-4adc-b80d-b18ff46ca120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Latex Foley Catheter
• Version Model Number: F01A041220
• Company DUNS: 544811862
• Company Name: Well Lead Medical Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06925816600098 [Primary]
GS1	16925816600095 [Package]; Contains: 06925816600098; Package: Box [10 Units]; In Commercial Distribution
GS1	26925816600092 [Package]; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082815

FDA Product Code

• MJC: Catheter, Urological (Antimicrobial) And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [Latex Foley Catheter]

• 16944932764061: 3 way standard 26Fr30-50ml
• 16944932764054: 3 way standard 26Fr5-15ml
• 16944932764030: 3 way standard 24Fr30-50ml
• 16944932764016: 3 way standard 24Fr5-15ml
• 16944932764009: 3 way standard 24Fr5-10ml
• 16944932763972: 3 way standard 22Fr30-50ml
• 16944932763958: 3 way standard 22Fr5-15ml
• 16944932763941: 3 way standard 22Fr5-10ml
• 16944932763910: 3 way standard 20Fr30-50ml
• 16944932763897: 3 way standard 20Fr5-15ml
• 16944932763880: 3 way standard 20Fr5-10ml
• 16944932763859: 3 way standard 18Fr30-50ml
• 16944932763835: 3 way standard 18Fr5-15ml
• 16944932763828: 3 way standard 18Fr5-10ml
• 16944932763804: 3 way standard 16Fr30-50ml
• 16944932763781: 3 way standard 16Fr5-15ml
• 16944932762371: 2 way Female 26Fr5-15ml
• 16944932762364: 2 way Female 24Fr30ml
• 16944932762340: 2 way Female 24Fr5-15ml
• 16944932762333: 2 way Female 22Fr30ml
• 16944932762302: 2 way Female 22Fr5-15ml
• 16944932762296: 2 way Female 22Fr5-10ml
• 16944932762289: 2 way Female 22Fr5ml
• 16944932762272: 2 way Female 20Fr30ml
• 16944932762258: 2 way Female 20Fr10ml
• 16944932762234: 2 way Female 20Fr5-15ml
• 16944932762227: 2 way Female 20Fr5-10ml
• 16944932762210: 2 way Female 20Fr5ml
• 16944932762203: 2 way Female 18Fr30ml
• 16944932762180: 2 way Female 18Fr10ml
• 16944932762166: 2 way Female 18Fr5-15ml
• 16944932762159: 2 way Female 18Fr5-10ml
• 16944932762142: 2 way Female 18Fr5ml
• 16944932762135: 2 way Female 16Fr30ml
• 16944932762111: 2 way Female 16Fr15ml
• 16944932762104: 2 way Female 16Fr10ml
• 16944932762081: 2 way Female 16Fr5-10ml
• 16944932762074: 2 way Female 16Fr5ml
• 16944932762067: 2 way Female 14Fr30ml
• 16944932762050: 2 way Female 14Fr15-30ml
• 16944932762043: 2 way Female 14Fr15ml
• 16944932762036: 2 way Female 14Fr10ml
• 16944932762012: 2 way Female 14Fr5-15ml
• 16944932762005: 2 way Female 14Fr5-10ml
• 16944932761992: 2 way Female 14Fr5ml
• 16944932761985: 2 way Female 12Fr30ml
• 16944932761978: 2 way Female 12Fr15ml
• 16944932761961: 2 way Female 12Fr10ml
• 16944932761947: 2 way Female 12Fr5-15ml
• 16944932761930: 2 way Female 12Fr5-10ml