Catalog Number

11012-016-50

Brand Name

Welch Allyn, Inc.

Version/Model Number

901134

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

-

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

14e7ebb3-140c-4d8b-ae34-55f3d90f2018

Public Version Date

June 28, 2022

Public Version Number

3

DI Record Publish Date

September 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-