Catalog Number

01500A3

Brand Name

Tecnimed - BV Medical

Version/Model Number

Thermofocus 01500

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

K072108,K072108,K072108,K072108,K072108

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

161de57e-e3da-41d3-9008-79a10f932f68

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

00182097000108

Quantity per Package

150

Contains DI Package

00182097000061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box