Beacon Care Package - Surface

Basic Information

• Brand Name: Beacon Care Package - Surface
• Primary DI: 00850011006016
• Version / Model: ASM0485-000
• Catalog Number: ASM0485-000
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 070809675
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ea3dccf9-9088-44f9-abfb-b328df57730d

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45065	Real-time position management respiratory gating system, optical	An assembly of electronic devices designed to track the respiratory pattern of a patient by means of optical technology to correlate tumour position with the respiratory cycle during radiation treatment planning, radiotherapy, computed tomography (CT) imaging, or other radiation procedures. It provides real-time position management (RPM) and involves optical-based tracking (e.g., video, infrared, laser) of the respiratory cycle to enable irradiation control during the procedure. It may include a tracking camera connected to a dedicated personal computer workstation and a reflective chest wall/abdominal marker.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011006016	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112841	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 131 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Humidity: between 20 and 80 Percent (%) Relative Humidity