← Back to catalogue

Beacon Care Package - Surface

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
Beacon Care Package - Surface FDA UDI
Generic Name
Real-time position management respiratory gating system, optical FDA UDI
Device Name
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. FDA UDI
Model / Reference
ASM0485-000 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
ASM0485-000 FDA UDI
Primary DI / UDI-DI
00850011006016 FDA UDI
510(k) Number
K112841 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Real-time position management respiratory gating system, optical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Real-time position management respiratory gating system, optical

Beacon Care Package - Surface by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Real-time position management respiratory gating system, optical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Varian Medical Systems, Inc

Sources (1)

  • FDA UDI ea3dccf9-9088-44f9-abfb-b328df57730d 37 fields · synced May 30, 2026