Catalog Number

-

Brand Name

firhealth

Version/Model Number

HW-F7

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173048,K173048,K173048

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

853a1e88-a25a-4823-9483-e72be0c614ec

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

June 22, 2020

Package DI Number

10810021178148

Quantity per Package

1

Contains DI Package

00810021178141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-