Catalog Number

-

Brand Name

Insta/Vent

Version/Model Number

IV-600S

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

K960397,K960397

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

e8c9f409-315c-435d-9d24-8a7bba1fb7fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Package DI Number

00857863007284

Quantity per Package

24

Contains DI Package

00857863007116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton