Catalog Number

060-137

Brand Name

Xenon Rebreathing System

Version/Model Number

060-137

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

528346e5-8bd1-49a5-a221-d60d50f0ae83

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 18, 2017

Package DI Number

30718175001401

Quantity per Package

15

Contains DI Package

00718175001370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box