Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

50052

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2019

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

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

51e436ad-98c7-4553-a4fb-3802ce3e440a

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 30, 2016

Package DI Number

30815067013372

Quantity per Package

100

Contains DI Package

00815067013371

Package Discontinue Date

May 07, 2019

Package Status

Not in Commercial Distribution

Package Type

-