Raycell

GUDID 00754014600106

Blood Irradiator

Best Theratronics Ltd

Ionizing-radiation blood irradiator

• Primary Device ID: 00754014600106
• NIH Device Record Key: 8868cdb3-8d33-4cda-affe-d5a63f65526b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Raycell
• Version Model Number: MK1
• Company DUNS: 243606832
• Company Name: Best Theratronics Ltd
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (613)5912100
• Email: compliance@theratronics.ca

Device Identifiers

Device Issuing Agency	Device ID
GS1	00754014600106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181737

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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [Raycell]

• 00754014600045: Blood Irradiator
• 00754014600106: Blood Irradiator
• 07540146000104: Blood Irradiator
• 07540146000043: Blood Irradiator