Duns Number:192559557
Device Description: Thoracic Vent Occlusion Plug
Catalog Number
TVOCP
Brand Name
Thora-Vent Thoracic Vent
Version/Model Number
TVOCP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 31, 2025
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
a8c87a8f-69bb-4e72-b796-a3b931eeae3a
Public Version Date
June 06, 2022
Public Version Number
3
DI Record Publish Date
September 07, 2016
Package DI Number
H862TVOCP2
Quantity per Package
10
Contains DI Package
H862TVOCP1
Package Discontinue Date
October 31, 2025
Package Status
In Commercial Distribution
Package Type
Shipper
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 179 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
U | Unclassified | 24 |