Catalog Number

-

Brand Name

PharmaSmart International, Inc

Version/Model Number

PS1000LED

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K811148

Product Code

DSK

Product Code Name

Computer, Blood-Pressure

Public Device Record Key

473e5df1-bfba-4aa6-a812-958cedd124d1

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-