Catalog Number

107984

Brand Name

Welch Allyn, Inc.

Version/Model Number

901066

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 25, 2021

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

K132807

Product Code

MWI

Product Code Name

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

Public Device Record Key

28b8c50a-24a2-4721-9a53-824772cfef4e

Public Version Date

January 26, 2021

Public Version Number

3

DI Record Publish Date

June 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-