Beacon Care Package - Surface ASM0485-000

GUDID 00850011006016

The Beacon transponder is a wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The resonance signal is used to measure the location of the transponders by the Calypso System. The Surface Beacon transponder is comprised of two Beacon transponders. The Surface Beacon transponder in its final packaged state is known as the Beacon Care Package - Surface.

VARIAN MEDICAL SYSTEMS, INC.

Real-time position management respiratory gating system, optical

• Primary Device ID: 00850011006016
• NIH Device Record Key: ea3dccf9-9088-44f9-abfb-b328df57730d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Beacon Care Package - Surface
• Version Model Number: ASM0485-000
• Catalog Number: ASM0485-000
• Company DUNS: 070809675
• Company Name: VARIAN MEDICAL SYSTEMS, 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: true
• Serial Number: false
• 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: +1(888)827-4265
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Humidity: between 20 and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011006016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112841

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: 2015-09-21

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

• 00856100006158 - Visual Coaching Device (VCD): 2023-11-22
• 00850800006067 - VariSeed: 2023-09-25
• 00858086006801 - IDENTIFY: 2023-08-14
• 00855141006202 - Eclipse Treatment Planning System: 2023-08-07
• 00899475002042 - Clinac iX: 2023-06-20
• 00899475002066 - Trilogy: 2023-06-20
• 00899475002080 - Novalis Tx: 2023-06-20
• 00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US: 2023-05-29