Catalog Number

-

Brand Name

BASE UNIT SERVO-U

Version/Model Number

6694800

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151814,K180098,K201874

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

4c09d224-0a5f-485a-8965-d068f7f370df

Public Version Date

June 09, 2021

Public Version Number

5

DI Record Publish Date

January 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-