Catalog Number

-

Brand Name

N/A

Version/Model Number

MN8040

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

adf53eb2-4b98-4711-afed-ec7eae99f0b9

Public Version Date

October 21, 2020

Public Version Number

5

DI Record Publish Date

June 09, 2017

Package DI Number

00857863007963

Quantity per Package

10

Contains DI Package

00857863007949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton