Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

50020

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)

Yes

Over the Counter (OTC)

-

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

5a9982d1-6276-4aca-b862-170c671b35a3

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

October 07, 2016

Package DI Number

80092237603822

Quantity per Package

264

Contains DI Package

00092237603826

Package Discontinue Date

May 07, 2019

Package Status

Not in Commercial Distribution

Package Type

CA