Catalog Number

44XT

Brand Name

Welch Allyn, Inc.

Version/Model Number

901057

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

MWI

Product Code Name

Monitor, physiological, patient (without arrhythmia detection or alarms)

Public Device Record Key

d66e82d9-1fb6-4e39-82cd-5cf0f933a4a4

Public Version Date

June 28, 2022

Public Version Number

5

DI Record Publish Date

April 26, 2021

Package DI Number

00732094309386

Quantity per Package

1

Contains DI Package

00732094309225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-