Duns Number:832696038
Device Description: PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home Use
Catalog Number
50-7700
Brand Name
PleurX
Version/Model Number
50-7700
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
DWM
Product Code Name
APPARATUS, SUCTION, PATIENT CARE
Public Device Record Key
9194a504-e76a-4217-b601-33f109f2be3f
Public Version Date
November 13, 2019
Public Version Number
4
DI Record Publish Date
September 15, 2017
Package DI Number
50885403231528
Quantity per Package
1
Contains DI Package
10885403231520
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |