Catalog Number

-

Brand Name

Caretouch

Version/Model Number

PSW01

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

34a5b94a-ed34-475e-8e79-252ae8a06eea

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 14, 2022

Package DI Number

16932825300472

Quantity per Package

18

Contains DI Package

06932825300475

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-