Red Rubber Urethral Catheters

GUDID 00616784506531

DYNAREX CORPORATION

Single-administration urethral drainage catheter

• Primary Device ID: 00616784506531
• NIH Device Record Key: 1c33a5f4-f3f9-45b4-8c09-51eb580c5d3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Red Rubber Urethral Catheters
• Version Model Number: 5065
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784506517 [Unit of Use]
GS1	00616784506524 [Primary]
GS1	00616784506531 [Package]; Contains: 00616784506524; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092250

FDA Product Code

• EYB: Catheter, Ureteral, Gastro-Urology

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Red Rubber Urethral Catheters]

• 00616784507033: 5070
• 00616784506937: 5069
• 00616784506838: 5068
• 00616784506739: 5067
• 00616784506630: 5066
• 00616784506531: 5065
• 00616784506432: 5064
• 00616784506333: 5063
• 00616784506234: 5062