Disposable Urinary Drainage Bag

GUDID 16974500612586

2000 mL Urinary Drainage Bag, Vented Anti-Reflux Chamber, 48" Drainage Tube, Handle, Sample Port, Cap

GCMEDICA ENTERPRISE LTD.(WUXI)

Non-wearable adult urine collection bag, closed-ended

• Primary Device ID: 16974500612586
• NIH Device Record Key: 968217f3-e589-4abf-91ff-8bc1518a7476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Urinary Drainage Bag
• Version Model Number: JH01B01
• 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	06974500612589 [Primary]
GS1	16974500612586 [Package]; Contains: 06974500612589; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• KNX: Collector, Urine, (And Accessories) For Indwelling Catheter

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

Devices Manufactured by GCMEDICA ENTERPRISE LTD.(WUXI)

• 16974500612555 - Disposable Urinary Leg Bag: 2025-08-15 500 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve
• 16974500612562 - Disposable Urinary Leg Bag: 2025-08-15 700 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve
• 16974500612579 - Disposable Urinary Leg Bag: 2025-08-15 1000 mL Urinary Leg Bag Equipped With 2 Flexible Straps, 1 Anti-Reflux Valve, and 1 Twist Valve
• 16974500612586 - Disposable Urinary Drainage Bag: 2025-08-152000 mL Urinary Drainage Bag, Vented Anti-Reflux Chamber, 48" Drainage Tube, Handle, Sample Port, Cap
• 16974500612586 - Disposable Urinary Drainage Bag: 2025-08-15 2000 mL Urinary Drainage Bag, Vented Anti-Reflux Chamber, 48" Drainage Tube, Handle, Sample Port, Cap
• 16974500612098 - Closed Suction Catheter: 2025-03-24 72H, FR10, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port
• 16974500612104 - Closed Suction Catheter: 2025-03-24 72H, FR12, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port
• 16974500612111 - Closed Suction Catheter: 2025-03-24 72H, FR14, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port
• 16974500612128 - Closed Suction Catheter: 2025-03-24 72H, FR16, Double swivel connector with 53.5cm tube, with MDI port and one-way irrigation port