Catalog Number

-

Brand Name

innoHaus

Version/Model Number

FT58

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

4034e6ab-83ee-4853-aa57-d4a4fc7c054f

Public Version Date

February 25, 2019

Public Version Number

2

DI Record Publish Date

December 17, 2018

Package DI Number

20853879007953

Quantity per Package

12

Contains DI Package

10853879007956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack