Catalog Number

00814088020597

Brand Name

ivWatch SmartTouch Sensor

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

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

K192385,K192385

Product Code

PMS

Product Code Name

Peripheral Intravenous (Piv) Infiltration Monitor

Public Device Record Key

ff0e82d2-6001-40c8-8904-82ebd38da82e

Public Version Date

July 27, 2020

Public Version Number

1

DI Record Publish Date

July 17, 2020

Package DI Number

20814088020591

Quantity per Package

80

Contains DI Package

00814088020597

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case