ViSi - ViSi chest sensor is an accessory intended to use - Sotera Wireless, Inc.

Duns Number:167142491

Device Description: ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to ViSi chest sensor is an accessory intended to use together with the ViSi Mobile Monitor to measure ECG, heart rate, respiration rate and temperature of adult patients (18 years or older).

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More Product Details

Catalog Number

93-10015

Brand Name

ViSi

Version/Model Number

Chest Sensor, 3 Lead, AAMI, WH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K152341

Product Code Details

Product Code

DRT

Product Code Name

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Device Record Status

Public Device Record Key

ebb9a043-e057-467e-ad38-7061c67dce4a

Public Version Date

May 16, 2022

Public Version Number

7

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOTERA WIRELESS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 29