Catalog Number

1960-RNBPU

Brand Name

RVS-100

Version/Model Number

1960-RNBPU

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

K170538

Product Code

MWI

Product Code Name

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Public Device Record Key

bb3c6403-e704-4425-aab0-bf48e3a65483

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

May 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-