Active Breathing Coordinator

GUDID 05060191071284

Control Module, Active Breathing Coordinator

ELEKTA LIMITED

Real-time position management respiratory gating system, optical

• Primary Device ID: 05060191071284
• NIH Device Record Key: b2b913d8-5fc7-4d5a-bf4e-a03a32e3f628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Active Breathing Coordinator
• Version Model Number: 1528859
• Company DUNS: 525557559
• Company Name: ELEKTA LIMITED
• 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: +1(855)693-5358
• Email: systems.support.na@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060191071284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151097

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-16

On-Brand Devices [Active Breathing Coordinator]

• 05060191071284: Control Module, Active Breathing Coordinator
• 05060191071277: Active Breathing Coordinator