Catalog Number

-

Brand Name

Zoe+Ruth Forehead and Ear - Object Digital Thermometer

Version/Model Number

ZR-FE501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 30, 2025

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K182133

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

64228d00-6de8-4b23-86c5-f8f6121a03dd

Public Version Date

April 27, 2020

Public Version Number

3

DI Record Publish Date

November 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-