Catalog Number

-

Brand Name

AEON

Version/Model Number

A310

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

K153021,K153021,K153021

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

179fa82a-a492-4625-9e66-53e169689569

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 28, 2018

Package DI Number

36947832500030

Quantity per Package

100

Contains DI Package

06947832500039

Package Discontinue Date

September 28, 2018

Package Status

Not in Commercial Distribution

Package Type

-