AccessGUDID - DEVICE: Beacon Care Package

GUDID

Device Identifier (DI) Information

Brand Name: Beacon Care Package - Surface
Version or Model: ASM0485-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASM0485-000
Company Name: VARIAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00850011006016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070809675 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112841	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 131 Degrees Fahrenheit
Special Storage Condition, Specify: Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea3dccf9-9088-44f9-abfb-b328df57730d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2015