Catalog Number

97-10259

Brand Name

ViSi

Version/Model Number

ViSi Emergency Medical Surveillance (EMS) Kit

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

K152341

Product Code

DSI

Product Code Name

Detector And Alarm, Arrhythmia

Public Device Record Key

ca7ddc65-388c-4dd1-8270-1b9bd25a1b4d

Public Version Date

May 16, 2022

Public Version Number

3

DI Record Publish Date

June 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-