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

April 30, 2026

Issuing Agency

In HIBCC

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

e91ef1d2-d163-4553-ab2b-ee5f20b7675b

Public Version Date

March 25, 2022

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

H862TV11132

Quantity per Package

10

Contains DI Package

H862TV11131

Package Discontinue Date

April 30, 2026

Package Status

In Commercial Distribution

Package Type

Shipper