Catalog Number

-

Brand Name

Hilo Pure

Version/Model Number

THD2FE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

110391d8-03a9-4ea0-9659-3047871597c9

Public Version Date

April 12, 2022

Public Version Number

4

DI Record Publish Date

June 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-