Catalog Number

18-935-000

Brand Name

HealthSmart

Version/Model Number

18-935-000

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100488,K100488

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0aa21ff7-c1cc-487f-a682-e69911d94fd5

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10767056189352

Quantity per Package

48

Contains DI Package

00767056189355

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton