Catalog Number

-

Brand Name

WRISTECH

Version/Model Number

ZB-3649

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

K990807,K990807

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

95b48f74-fd37-4100-9266-4acfb315f3c4

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 17, 2016

Package DI Number

14719872480188

Quantity per Package

24

Contains DI Package

04719872480181

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-