Catalog Number

-

Brand Name

AEON

Version/Model Number

A340L

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190869,K190869

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

909d70d6-95bc-471e-9107-1b92bcbef6c9

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

April 21, 2020

Package DI Number

46947832500099

Quantity per Package

150

Contains DI Package

06947832500091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-