Catalog Number

419593

Brand Name

Welch Allyn, Inc.

Version/Model Number

901065

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 23, 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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101680

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

e92a76da-2100-46c9-813f-ade987c31d72

Public Version Date

April 26, 2021

Public Version Number

2

DI Record Publish Date

July 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-