Catalog Number

-

Brand Name

agelh

Version/Model Number

BW-601

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K193628,K193628

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

53d4cd3d-73d3-4246-b5b3-34d77a3b1728

Public Version Date

February 22, 2021

Public Version Number

2

DI Record Publish Date

December 18, 2020

Package DI Number

16973826010694

Quantity per Package

36

Contains DI Package

06973826010697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-