Catalog Number

TV11-13

Brand Name

Thora-Vent Thoracic Vent

Version/Model Number

TV11-13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

826242fd-c077-40c4-8418-617b96c8af85

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Package DI Number

10817640020766

Quantity per Package

1

Contains DI Package

00817640020769

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser