Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

50052

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 21, 2016

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)

Yes

Over the Counter (OTC)

-

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

f67b0283-8ba2-4f29-97ce-36b9837b5e61

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

80092237604591

Quantity per Package

100

Contains DI Package

00092237604595

Package Discontinue Date

November 21, 2016

Package Status

Not in Commercial Distribution

Package Type

CA