Duns Number:192559557
Device Description: THORA-VENT Procedure Tray - 13F 10cm
Catalog Number
TV13-10
Brand Name
Thora-Vent Thoracic Vent
Version/Model Number
TV13-10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
011a754c-fbe1-40e9-905f-d3ed44c6535a
Public Version Date
April 01, 2022
Public Version Number
1
DI Record Publish Date
March 24, 2022
Package DI Number
10817640020773
Quantity per Package
1
Contains DI Package
00817640020776
Package Discontinue Date
-
Package Status
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 |