Catalog Number

-

Brand Name

ReliOn

Version/Model Number

FHT6C-ROFP-1_0

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

K032362,K032362,K032362

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

c079934e-1279-4412-b120-0a5a4b39899f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20762012062714

Quantity per Package

12

Contains DI Package

10762012062717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Box