Catalog Number

-

Brand Name

1BYONE

Version/Model Number

JPD-500D

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

K140582,K140582,K140582

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

94a517df-4d98-4b31-9dac-b2288d9c7725

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

November 10, 2016

Package DI Number

10863696000337

Quantity per Package

100

Contains DI Package

00863696000330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-