Catalog Number

177-091

Brand Name

Venti-Scan

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K871868,K871868,K871868,K871868

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

82a7f48e-8a22-411d-bcd8-ec872f8649c6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 02, 2016

Package DI Number

30718175001944

Quantity per Package

50

Contains DI Package

00718175001912

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box