Catalog Number

-

Brand Name

HealthWise

Version/Model Number

59-363

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K983887,K983887

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

41dca499-d135-4706-91fd-42b7eb440859

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Package DI Number

10845717008997

Quantity per Package

12

Contains DI Package

00845717008990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton