Urinary Drainage Bag

GUDID 00616784427034

DYNAREX CORPORATION

Non-wearable urine collection bag, open-ended

• Primary Device ID: 00616784427034
• NIH Device Record Key: 95a31e04-b55b-4b13-8d2c-3a12a17526f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urinary Drainage Bag
• Version Model Number: 4270
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784427010 [Unit of Use]
GS1	00616784427034 [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: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-24

On-Brand Devices [Urinary Drainage Bag]

• 00616784427133: 4271
• 00616784427034: 4270