Catalog Number

OTW11-13

Brand Name

Thora-Vent Thoracic Vent

Version/Model Number

OTW11-13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2027

Issuing Agency

In HIBCC

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

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

290ceffe-91e7-43c2-b618-cb41f4a628d4

Public Version Date

June 06, 2022

Public Version Number

3

DI Record Publish Date

September 07, 2016

Package DI Number

H862OTW11132

Quantity per Package

5

Contains DI Package

H862OTW11131

Package Discontinue Date

January 01, 2027

Package Status

In Commercial Distribution

Package Type

Shipper