Catalog Number

RL322-05

Brand Name

ThermoStrip

Version/Model Number

RL322-05

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

-

Product Code

KPD

Product Code Name

Strip, Temperature, Forehead, Liquid Crystal

Public Device Record Key

f09f68bc-f688-45b0-8ac1-bd62979a2a27

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

30815236020637

Quantity per Package

12

Contains DI Package

20815236020630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Poly Bag