URO Saf-Gard Extension Tubing UROET18

GUDID 00868636000401

18 “Tubing

URO CONCEPTS INC

Urine monitoring system collector

• Primary Device ID: 00868636000401
• NIH Device Record Key: 86582283-a03e-499d-81e8-ee9a4d7ddaeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URO Saf-Gard Extension Tubing
• Version Model Number: 18 inch
• Catalog Number: UROET18
• Company DUNS: 169168882
• Company Name: URO CONCEPTS INC
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-282-6748
• Email: bruce@avcorhealthy.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868636000401 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-12
• Device Publish Date: 2019-08-03

On-Brand Devices [URO Saf-Gard Extension Tubing]

• 00868636000418: 48 “Tubing Length
• 00868636000401: 18 “Tubing