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

-

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"

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

6735405f-ee45-418e-a636-6cb1b9c0960d

Public Version Date

June 10, 2022

Public Version Number

1

DI Record Publish Date

June 02, 2022

Package DI Number

10817640020469

Quantity per Package

5

Contains DI Package

00817640020462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser