Catalog Number

-

Brand Name

Homedics

Version/Model Number

BPA-CUFFXL

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190507,K190507

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

e08f9310-aac3-424a-bdec-db631ee2105d

Public Version Date

October 14, 2021

Public Version Number

1

DI Record Publish Date

October 06, 2021

Package DI Number

14719872489167

Quantity per Package

24

Contains DI Package

04719872489160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-