RS

GUDID 00860000737005

Blood Irradiator

RAD SOURCE TECHNOLOGIES, INC.

Ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator In vitro ionizing-radiation blood irradiator

• Primary Device ID: 00860000737005
• NIH Device Record Key: 78c96013-beaa-4268-94e2-4782f1f445f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RS
• Version Model Number: 3400
• Company DUNS: 047783811
• Company Name: RAD SOURCE TECHNOLOGIES, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com
• Phone: 678-765-7900
• Email: compliance@radsource.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000737005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082921

FDA Product Code

• MOT: Irradiator, Blood To Prevent Graft Versus Host Disease

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-29