Catalog Number

-

Brand Name

ReliOn

Version/Model Number

WMTBPA-845

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092161,K092161

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

6e8c6ac1-bee0-45fd-a47c-95ba74b203ea

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

14719872483103

Quantity per Package

2

Contains DI Package

04719872483106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-