Catalog Number

16813

Brand Name

Rectal Temperature Digital Thermometer

Version/Model Number

16813

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"

Yes

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

K940686,K940686

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ed4a891d-91c1-4f1f-b6c0-fd0edcec4d48

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 18, 2017

Package DI Number

20612606001530

Quantity per Package

24

Contains DI Package

00612606001536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-