Catalog Number

-

Brand Name

Spectrum

Version/Model Number

SM109

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090014,K090014,K090014,K090014,K090014

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

0caf50c4-9f4f-41b7-8cbe-f51823a505e8

Public Version Date

December 10, 2018

Public Version Number

4

DI Record Publish Date

March 07, 2017

Package DI Number

00844064120171

Quantity per Package

25

Contains DI Package

00844064035635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Box