Catalog Number

-

Brand Name

HEB in Control

Version/Model Number

H-DTR60

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

K163518,K163518

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

7fa1b233-eb4f-48b3-ac16-82d736b0c6c1

Public Version Date

November 01, 2021

Public Version Number

1

DI Record Publish Date

October 22, 2021

Package DI Number

10041220873866

Quantity per Package

144

Contains DI Package

00041220873869

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-