Catalog Number

-

Brand Name

Nellcor

Version/Model Number

10005063

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

Yes

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

71934303-6dbc-47be-a7c2-1d81e5b2d4af

Public Version Date

August 31, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2017

Package DI Number

10884521080553

Quantity per Package

18

Contains DI Package

20884521080550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE