Catalog Number

177-091

Brand Name

Venti-Scan IV Convenience Kit, 12 inch tubing

Version/Model Number

177-091

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K871868

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

aa4c8bdd-d6f0-4cd1-8048-dcfbafaf62a8

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-