Catalog Number

-

Brand Name

Nellcor

Version/Model Number

RS10

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

K904039,K904039,K904039

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

30e064af-ab41-47c4-abd3-25d71433e657

Public Version Date

August 31, 2022

Public Version Number

5

DI Record Publish Date

May 27, 2017

Package DI Number

30884522042523

Quantity per Package

3

Contains DI Package

20884522042526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE