Catalog Number

-

Brand Name

Nonin

Version/Model Number

9840SA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K982969,K982969,K982969

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

ac40d87c-fee8-4187-9f02-0fb796f96699

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 24, 2016

Package DI Number

00833166002355

Quantity per Package

12

Contains DI Package

00849686074482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag