Catalog Number

-

Brand Name

ByFloProducts

Version/Model Number

PG-IRT1602

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

df850668-142e-44e8-900c-64072aea20c2

Public Version Date

February 18, 2022

Public Version Number

2

DI Record Publish Date

February 09, 2022

Package DI Number

10628693098011

Quantity per Package

60

Contains DI Package

00628693098014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box