Catalog Number

-

Brand Name

AEON

Version/Model Number

A201

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

K171578,K171578,K171578

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ab2928f2-e76b-45f7-9ed9-aaba0307974d

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

August 17, 2018

Package DI Number

26947832500095

Quantity per Package

80

Contains DI Package

06947832500138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-