Catalog Number

-

Brand Name

Caretouch

Version/Model Number

PSW01-B

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

a06fdd62-2394-48b7-aeb0-4a13b87642b2

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

26932825300004

Quantity per Package

18

Contains DI Package

16932825300014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-