Catalog Number

-

Brand Name

NatureSpirit

Version/Model Number

KD-5904

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

K070826,K070826

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

1ed5e649-6e31-4424-84ad-dbfe4b19d6a8

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

February 24, 2017

Package DI Number

00897037001823

Quantity per Package

12

Contains DI Package

00897037001038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton