PVC Urethral Catheter

GUDID 16936881134514

Pediatric, 1-way 6Fr

Well Lead Medical Co.,Ltd

Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter Single-administration urethral drainage/irrigation catheter

• Primary Device ID: 16936881134514
• NIH Device Record Key: 580dab49-d043-4788-bd40-24f99ee89f32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PVC Urethral Catheter
• Version Model Number: F01D01061F
• 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	06936881134517 [Primary]
GS1	16936881134514 [Package]; Contains: 06936881134517; Package: Box [100 Units]; In Commercial Distribution
GS1	26936881134511 [Package]; Package: Carton [6 Units]; In Commercial Distribution

FDA Product Code

• EZD: Catheter, Straight

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: 2024-05-07
• Device Publish Date: 2024-04-29

On-Brand Devices [PVC Urethral Catheter]

• 16936881134606: Male(standard), 1-way 24Fr
• 16936881134590: Male(standard), 1-way 22Fr
• 16936881134583: Male(standard), 1-way 20Fr
• 16936881134576: Male(standard), 1-way 18Fr
• 16936881134569: Male(standard), 1-way 16Fr
• 16936881134552: Male(standard), 1-way 14Fr
• 16936881134545: Male(standard), 1-way 12Fr
• 16936881134538: Pediatric, 1-way 10Fr
• 16936881134521: Pediatric, 1-way 8Fr
• 16936881134514: Pediatric, 1-way 6Fr
• 16936881134507: Female, 1-way 24Fr
• 16936881134491: Female, 1-way 22Fr
• 16936881134484: Female, 1-way 20Fr
• 16936881134477: Female, 1-way 18Fr
• 16936881134460: Female, 1-way 16Fr
• 16936881134453: Female, 1-way 14Fr
• 16936881134446: Female, 1-way 12Fr