Catalog Number

-

Brand Name

WilBee

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

a5b70dc1-36ca-4679-b84f-0851fd81eebb

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

June 20, 2020

Package DI Number

10810021178063

Quantity per Package

1

Contains DI Package

00810021178066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-