Catalog Number

-

Brand Name

1BYONE

Version/Model Number

JPD-FR401

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"

Yes

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

56442285-ab8d-497f-9aeb-c386e61c0251

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

November 10, 2016

Package DI Number

10863696000351

Quantity per Package

100

Contains DI Package

00863696000354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-