Catalog Number

24161

Brand Name

Stellar

Version/Model Number

150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

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

-

Product Code

MNT

Product Code Name

Ventilator, Continuous, Minimal Ventilatory Support,Facility Use

Public Device Record Key

dc1c5146-7f45-4fdd-98d5-a744b0307e7d

Public Version Date

July 23, 2021

Public Version Number

3

DI Record Publish Date

October 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-