Catalog Number

ASM0341

Brand Name

Calypso Beacon Care Package-Lung

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170570

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

cd2dcf3d-8d2b-468f-97b7-029f39c05c42

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

September 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-