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)

• 16974500613552 - Elbow Support: 2025-12-22 Resuable and Adjustable Elbow Support Matrials: Nylon, Neoprene Size: One Size,fits left and right Elbow
• 16974500613569 - Compression Gloves: 2025-12-22 Resuable and Adjustable Compression Gloves Materials: Copper fibers, Spandex Size: L,XL
• 16974500613576 - Knee Brace: 2025-12-22 Adjustable Knee Brace Materials: Nylon, Neoprene Size: One Size,fits left and right Knee
• 16974500613583 - Knee brace: 2025-12-22 Adjustable Knee Brace Materials: Polyester, Rubber fibers Size: L/XL,fits left and right Knee
• 16974500613590 - Shoulder Brace: 2025-12-22 Resuable and Adjustable Shoulder Brace Materials: Nylon,Neoprene Size: One Size,fits left and right shoulder
• 16974500613606 - Cervical Collar: 2025-12-22 Reusable and Adjustable Cervical Collar Materials:Nylon ,Sponge Size:One Size
• 16974500613613 - Arm Sling: 2025-12-22 Reusable and Adjustable Arm Sling Materials: Polyester,Sponge Size: One Size,fits left and right arm
• 16974500613620 - Arm Sling: 2025-12-22 Reusable and Adjustable Arm Sling Materials: Polyester, Nylon Size: One Size,fits left and right arm