Duns Number:832696038
Device Description: PleurX Supplemental Insertion Kit
Catalog Number
50-7262
Brand Name
PleurX
Version/Model Number
50-7262
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"
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
874e2f6e-c18e-4c01-8fe0-2a0de65e647b
Public Version Date
November 13, 2019
Public Version Number
3
DI Record Publish Date
June 12, 2017
Package DI Number
50885403193024
Quantity per Package
5
Contains DI Package
10885403193026
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 |