Catalog Number

-

Brand Name

Care Touch

Version/Model Number

ET-110

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110776,K110776

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

4b67c207-153f-46b8-a07e-923bedd88aeb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

20370393421015

Quantity per Package

300

Contains DI Package

00370393421011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-