Duns Number:832696038
Device Description: Catheter Access Kit, For use with the PleurX or PeritX Catheter Systems
Catalog Number
50-7280A
Brand Name
N/A
Version/Model Number
50-7280A
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
b0d72cda-2e62-4412-94d0-58d4c47505a9
Public Version Date
March 18, 2021
Public Version Number
2
DI Record Publish Date
March 09, 2021
Package DI Number
50885403502406
Quantity per Package
5
Contains DI Package
10885403502408
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 |