Catalog Number

WAH-KIT-MKS

Brand Name

Welch Allyn, Inc.

Version/Model Number

901042

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 11, 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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Public Device Record Key

11a33e9d-39b6-41a2-8350-6387a2ed9f00

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

February 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-