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

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

a9f6a4d2-57c4-4b68-bcda-7ff90056d1c9

Public Version Date

May 20, 2019

Public Version Number

1

DI Record Publish Date

May 10, 2019

Package DI Number

00844064035550

Quantity per Package

50

Contains DI Package

00844064035567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard