Catalog Number

-

Brand Name

Regard™

Version/Model Number

303413

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

K903590,K903590,K903590

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a31bcd26-b435-42fa-96ad-7da8ca422283

Public Version Date

March 24, 2020

Public Version Number

2

DI Record Publish Date

October 30, 2019

Package DI Number

10326053105019

Quantity per Package

144

Contains DI Package

00326053105012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-