Catalog Number

-

Brand Name

Nellcor

Version/Model Number

D-YSE

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

K012891,K012891

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

492c8fbb-ecfd-4d6c-adef-3b00d89ffcb3

Public Version Date

August 31, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884522042564

Quantity per Package

200

Contains DI Package

10884522042567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE