Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs

GUDID 00616784429038

DYNAREX CORPORATION

Wearable urine collection bag, open-ended

• Primary Device ID: 00616784429038
• NIH Device Record Key: 283c4229-293b-44f6-9506-5ca37807dd27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs
• Version Model Number: 4290
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784429014 [Unit of Use]
GS1	00616784429038 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-09-13

Devices Manufactured by DYNAREX CORPORATION

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• 00810180845106 - Cotton Tipped Wood Applicators, Sterile: 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 1 per pouch
• 00810180845113 - Cotton Tipped Wood Applicators, Sterile: 2026-03-30 Cotton Tipped Wood Applicators, Sterile, 6", 2 per Pouch
• 00810180840712 - CurPro Dermal Curettes,2 mm: 2026-03-27 Sterile-R
• 00840117347892 - Medi-Cut Safety Scalpel: 2026-03-27 Medi-Cut Safety Scalpel, Sterile, # 15
• 00810180844901 - Disposable Prep Razors: 2026-03-25 Disposable Prep Razors
• 00810180844918 - Medicine Cups 1oz: 2026-03-25
• 00810180844925 - LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal: 2026-03-25 Sterile-EO