Catalog Number

06138-000

Brand Name

Welch Allyn, Inc.

Version/Model Number

901010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K022163

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

8cc7285c-b67b-4b11-b5c1-b6f5d5dc7026

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

December 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-