Duns Number:621904622
Device Description: Chinook Chest Drain Valve is used for chest drainage into a collection device. This one-wa Chinook Chest Drain Valve is used for chest drainage into a collection device. This one-way valve connects to chest tubing and only allows fluid and air to pass in one direction.
Catalog Number
99671
Brand Name
Chinook Chest Drain Valve
Version/Model Number
99671
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2021
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
5c28d89c-919b-4f86-b990-a40d49895a2c
Public Version Date
April 02, 2021
Public Version Number
2
DI Record Publish Date
December 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 30 |