Bryton Corporation

GUDID 00618125161119

Bryton Corporation Urology Drain Bags Vinyl Fits Hoop Style Urology Frames 20 per Case

TIDI PRODUCTS, LLC

Non-wearable adult urine collection bag, open-ended

• Primary Device ID: 00618125161119
• NIH Device Record Key: 338169ad-df6c-4768-8663-331becdd294d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bryton Corporation
• Version Model Number: 32758
• Company DUNS: 063519193
• Company Name: TIDI PRODUCTS, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618125161119 [Package]; Contains: 01618125161118; Package: [20 Units]; In Commercial Distribution
GS1	01618125161118 [Primary]

FDA Product Code

• NNW: Bag, Urine Collection, Leg, For External Use, Non-Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-08-29
• Device Publish Date: 2016-10-12

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