Catalog Number

-

Brand Name

ivWatch Sensor Receptacle

Version/Model Number

Model 400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

For Single-Use

Yes

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

3907fc88-d7fb-49a4-9b2f-8b64f0c361d1

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

10814088020013

Quantity per Package

50

Contains DI Package

00814088020016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack