Catalog Number

-

Brand Name

Nonin

Version/Model Number

LS1 PS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

118294fd-abf7-4bf4-8f8f-8ee9eafde448

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

00849686070354

Quantity per Package

1

Contains DI Package

00849686092660

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag