Duns Number:080935429
Device Description: Chest Drainage Unit,Three Chamber System, Collection, Underwater Seal and Suction Control Chest Drainage Unit,Three Chamber System, Collection, Underwater Seal and Suction Control Chambers, Autotransfusion Ready
Catalog Number
8884713176
Brand Name
Thora-Seal
Version/Model Number
8884713176
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"
-
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
7730d145-63a0-4588-9439-2f1256a95e6b
Public Version Date
January 08, 2021
Public Version Number
6
DI Record Publish Date
August 30, 2015
Package DI Number
10884521074149
Quantity per Package
4
Contains DI Package
20884521074146
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |