Catalog Number

-

Brand Name

agelh

Version/Model Number

BA-801X

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

K193627,K193627

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

77f201d0-6954-40dd-a8ab-f2dafc4fe1da

Public Version Date

December 27, 2021

Public Version Number

3

DI Record Publish Date

December 17, 2020

Package DI Number

16973826010557

Quantity per Package

24

Contains DI Package

06973826010550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-