Catalog Number

-

Brand Name

Nellcor

Version/Model Number

AI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2019

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

K012891,K012891

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

ea438240-1c1f-4b3e-b8ee-1d6686122a0e

Public Version Date

August 31, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884522042130

Quantity per Package

24

Contains DI Package

20884522042137

Package Discontinue Date

June 17, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE