Catalog Number

0800H5

Brand Name

Tecnimed - BV Medical

Version/Model Number

Thermofocus 0800

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

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

ceaf4322-95bd-42a3-beaf-6a3a6bba0b5b

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

00182097000115

Quantity per Package

90

Contains DI Package

00182097000078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box