Catalog Number

041900000

Brand Name

DT-4812A Single Transducer Set

Version/Model Number

041900000

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

Yes

Prescription Use (Rx)

Yes

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

914e4b02-3bd0-48d0-bcf0-5beb4d6d01b4

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20886333220308

Quantity per Package

10

Contains DI Package

00886333220304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box