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

• 00810180842617 - DynaLube, Lubricating Jelly Sterile, 5 g: 2026-02-04
• 00810180842600 - DynaLube, Lubricating Jelly Sterile, 2.7 g Packet: 2026-02-03
• 00840117348790 - Flavored Oral Swab, For Professional And Hospital use: 2026-01-29 Individually Wrapped
• 00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use: 2026-01-29 Individually Wrapped
• 00840117348837 - Oral Swabsticks, Flavored w/Dentrifice: 2026-01-29
• 00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use: 2026-01-29
• 00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal: 2026-01-13
• 00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal: 2026-01-13