Catalog Number

419770

Brand Name

Welch Allyn, Inc.

Version/Model Number

901144

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 17, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K152944

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

b02ea72d-359a-484f-8882-d5da1a2942e2

Public Version Date

December 18, 2020

Public Version Number

2

DI Record Publish Date

February 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-