Catalog Number

00814088020382

Brand Name

ivWatch Patient Monitor

Version/Model Number

Model 400

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

PMS

Product Code Name

Peripheral Intravenous (Piv) Infiltration Monitor

Public Device Record Key

d3f72774-3b9c-4947-94de-a7e076a4c149

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-