Catalog Number

-

Brand Name

Nonin

Version/Model Number

7600TC-3

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MUD

Product Code Name

Oximeter, Tissue Saturation

Public Device Record Key

5476583d-7774-4587-a2a0-6af91998574f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 03, 2016

Package DI Number

00833166007626

Quantity per Package

1

Contains DI Package

00849686071030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag