RIVA CON-0100-9

GUDID 00691794010001

A device used to prepare IV bags and syringes for hospital and compounding pharmacies.

ARxIUM Inc

Peripheral intravenous catheterization support kit

• Primary Device ID: 00691794010001
• NIH Device Record Key: 815ac811-39b4-4a6e-9d74-0aacfb7442c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA
• Version Model Number: 100000
• Catalog Number: CON-0100-9
• Company DUNS: 202676839
• Company Name: ARxIUM 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: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 847-495-3140
• Email: cross@arxium.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 81.2 KiloPascal and 101 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00691794010001 [Primary]

FDA Product Code

• NEP: System/Device, Pharmacy Compounding

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-24
• Device Publish Date: 2016-09-10

On-Brand Devices [RIVA]

• 01691794010001: A device use to prepare IV’s and syringes for hospital pharmacies.
• 00691794010001: A device used to prepare IV bags and syringes for hospital and compounding pharmacies.