Catalog Number

HTD8815US

Brand Name

Equate

Version/Model Number

HTD8813C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K203332,K203332

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ba279141-b161-46c3-9846-3e9f1bc9cd80

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Package DI Number

10681131405895

Quantity per Package

6

Contains DI Package

00681131405898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-