Catalog Number

-

Brand Name

Stasis Labs

Version/Model Number

Stasis Monitoring System

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

-

Product Code

MWI

Product Code Name

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Public Device Record Key

2970c662-787e-47b2-bf41-51a02d838c55

Public Version Date

April 18, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2019

Package DI Number

10854271008008

Quantity per Package

8

Contains DI Package

00854271008001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case