Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

RMI-POX2D:

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)

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

6b815c61-f015-42af-ac1f-5e9aad5fb9b9

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

October 27, 2016

Package DI Number

80092237603839

Quantity per Package

240

Contains DI Package

00092237603833

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA