Catalog Number

-

Brand Name

ReliOn

Version/Model Number

C29

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

dbf58e2f-7f07-47ff-b62a-9b3a73b315c9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 12, 2016

Package DI Number

10681131078525

Quantity per Package

2

Contains DI Package

00681131078528

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack