Catalog Number

26025-092-404

Brand Name

Welch Allyn, Inc.

Version/Model Number

901078

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2019

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

747f8ef9-5f52-4c2b-a6f5-01e4ff7faad2

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

May 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-