Catalog Number

-

Brand Name

Model Eagle II, MRI

Version/Model Number

799-EGL2-02-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111473

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

ee4d2e43-ba32-4899-ae4e-5fdb0b450b80

Public Version Date

October 30, 2020

Public Version Number

1

DI Record Publish Date

October 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-