Catalog Number

132-680

Brand Name

Xenon Rebreathing System

Version/Model Number

132-680

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

eddf06a0-a954-4117-bdbe-c5f74345d6d3

Public Version Date

October 08, 2019

Public Version Number

1

DI Record Publish Date

September 30, 2019

Package DI Number

10718175005009

Quantity per Package

25

Contains DI Package

00718175005002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box