All Silicone Foley Catheter

GUDID 16944932753546

2-way Standard 16Fr5mL

Well Lead Medical Co.,Ltd

Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 16944932753546
• NIH Device Record Key: b190c28e-fde7-4eae-a0f2-7a6ec70a95ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Silicone Foley Catheter
• Version Model Number: F01B011604
• 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	06944932753549 [Primary]
GS1	16944932753546 [Package]; Contains: 06944932753549; Package: Box [10 Units]; In Commercial Distribution
GS1	26944932753543 [Package]; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082815

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

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: 2024-05-27
• Device Publish Date: 2024-05-17

On-Brand Devices [All Silicone Foley Catheter]

• 16944932755458: 3-way Standard 26Fr30ml
• 16944932755441: 3-way Standard 26Fr15ml
• 16944932755434: 3-way Standard 26Fr10ml
• 16944932755427: 3-way Standard 26Fr5-15ml
• 16944932755410: 3-way Standard 26Fr5-10ml
• 16944932755397: 3-way Standard 24Fr30ml
• 16944932755380: 3-way Standard 24Fr15ml
• 16944932755373: 3-way Standard 24Fr10ml
• 16944932755366: 3-way Standard 24Fr5-15ml
• 16944932755342: 3-way Standard 24Fr5-10ml
• 16944932755328: 3-way Standard 22Fr30ml
• 16944932755311: 3-way Standard 22Fr15ml
• 16944932755304: 3-way Standard 22Fr10ml
• 16944932755298: 3-way Standard 22Fr5-15ml
• 16944932755281: 3-way Standard 22Fr5-10ml
• 16944932755267: 3-way Standard 20Fr30ml
• 16944932755250: 3-way Standard 20Fr15ml
• 16944932755243: 3-way Standard 20Fr10ml
• 16944932755236: 3-way Standard 20Fr5-15ml
• 16944932755229: 3-way Standard 20Fr5-10ml
• 16944932755205: 3-way Standard 18Fr30ml
• 16944932755199: 3-way Standard 18Fr15ml
• 16944932755182: 3-way Standard 18Fr10ml
• 16944932755175: 3-way Standard 18Fr5-15ml
• 16944932755168: 3-way Standard 18Fr5-10ml
• 16944932755144: 3-way Standard 16Fr30ml
• 16944932755137: 3-way Standard 16Fr15ml
• 16944932755120: 3-way Standard 16Fr10ml
• 16944932755113: 3-way Standard 16Fr5-15ml
• 16944932755106: 3-way Standard 16Fr5-10ml
• 16944932754383: 2-way Female 14Fr10ml
• 16944932754376: 2-way Female 14Fr5-15ml
• 16944932754369: 2-way Female 14Fr5-10ml
• 16944932754345: 2-way Female 12Fr10ml
• 16944932754338: 2-way Female 12Fr5-15ml
• 16944932754321: 2-way Female 12Fr5-10ml
• 16944932754000: 2-way Standard 26Fr30ml
• 16944932753997: 2-way Standard 26Fr10ml
• 16944932753980: 2-way Standard 26Fr5-15ml
• 16944932753973: 2-way Standard 26Fr5-10ml
• 16944932753966: 2-way Standard 26Fr5ml
• 16944932753942: 2-way Standard 24Fr30ml
• 16944932753928: 2-way Standard 24Fr15ml
• 16944932753911: 2-way Standard 24Fr10ml
• 16944932753904: 2-way Standard 24Fr5-15ml
• 16944932753898: 2-way Standard 24Fr5-10ml
• 16944932753881: 2-way Standard 24Fr5ml
• 16944932753867: 2-way Standard 22Fr30ml
• 16944932753843: 2-way Standard 22Fr15ml
• 16944932753836: 2-way Standard 22Fr10ml