Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

HW-B05

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

6d6e0497-0a23-40ef-b56e-f87f9aba553c

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 05, 2021

Package DI Number

10810021178391

Quantity per Package

1

Contains DI Package

00810021178387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-