Catalog Number

L320-100

Brand Name

CliniTrend

Version/Model Number

L320-100

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KPD

Product Code Name

Strip, Temperature, Forehead, Liquid Crystal

Public Device Record Key

9acc7f29-31b5-4bbc-a199-0f577e5a29d2

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

January 06, 2017

Package DI Number

20815236020906

Quantity per Package

1

Contains DI Package

10815236020909

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box