Catalog Number

-

Brand Name

caring mill

Version/Model Number

BP3NC1-2AFSA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

4f020fe0-45cc-4e64-9125-ab358b313902

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

January 29, 2018

Package DI Number

50861618000326

Quantity per Package

12

Contains DI Package

00861618000321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box packing