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
July 01, 2027
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
a25e7e24-928d-4626-90d2-6ceaf794a3cc
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
June 03, 2022
Package DI Number
10817640020797
Quantity per Package
5
Contains DI Package
00817640020790
Package Discontinue Date
July 01, 2027
Package Status
Not in Commercial Distribution
Package Type
Dispenser
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 |