Catalog Number

-

Brand Name

Equate

Version/Model Number

MD300CN310

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

Yes

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

a1e74ce0-f6db-4edf-9383-4033cadec45c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 22, 2017

Package DI Number

20681131235260

Quantity per Package

6

Contains DI Package

10681131235263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-