Disposable Urinary Leg Bag

GUDID 16974500612555

500 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve

GCMEDICA ENTERPRISE LTD.(WUXI)

Non-wearable adult urine collection bag, closed-ended

• Primary Device ID: 16974500612555
• NIH Device Record Key: 14cde34b-15ef-43b8-a290-1393ead0c94c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Urinary Leg Bag
• Version Model Number: JH02B01
• Company DUNS: 560122957
• Company Name: GCMEDICA ENTERPRISE LTD.(WUXI)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974500612558 [Primary]
GS1	16974500612555 [Package]; Contains: 06974500612558; Package: [48 Units]; In Commercial Distribution

FDA Product Code

• FAQ: Bag, Urine Collection, Leg, For External Use, Sterile

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: 2025-08-15
• Device Publish Date: 2025-08-07

On-Brand Devices [Disposable Urinary Leg Bag]

• 16974500612579: 1000 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve
• 16974500612562: 700 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve
• 16974500612555: 500 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve