Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

TMB-1583-S

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

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

20c096c4-eefc-4e22-8921-57a55a149c84

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Package DI Number

30694501169857

Quantity per Package

18

Contains DI Package

00694501169856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case