Catalog Number

-

Brand Name

AEON

Version/Model Number

A340B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 13, 2021

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

K200414,K200414,K200414,K200414,K200414

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

e8c3d748-f0bc-4abf-8017-fb1a838cc13f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 12, 2021

Package DI Number

16947832500470

Quantity per Package

50

Contains DI Package

06947832500473

Package Discontinue Date

October 13, 2021

Package Status

Not in Commercial Distribution

Package Type

-