Catalog Number

5316781

Brand Name

LEADER

Version/Model Number

5316781

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

DQA

Product Code Name

Oximeter

Public Device Record Key

74e99b1c-921b-4966-983c-0ffb1c724a82

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

July 07, 2017

Package DI Number

30096295131377

Quantity per Package

3

Contains DI Package

00096295131376

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX