Catalog Number

18-225-000

Brand Name

HealthSmart

Version/Model Number

18-225-000

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

Yes

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

K100488,K100488,K100488

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

fff9a6a7-040c-4f44-98eb-046900422681

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 17, 2017

Package DI Number

10767056182254

Quantity per Package

4

Contains DI Package

30767056182258

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton