Device
Automatic Continuous Effusion Shunt (ACES) System
Manufacturer
Pleural Dynamics, Inc.
Pleural Dynamics, Inc.
Model: AS16-7
DI: 00860011648109
Status: New
MRI: MR Safe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Automatic Continuous Effusion Shunt (ACES) System
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5febced0-21d9-497c-8db1-1cfe0dccc84f
Distribution Status:
In Commercial Distribution
DUNS Number:
117405409
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860011648109
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 59019
Name: Pleuroperitoneal shunt
Definition:
A sterile surgically implanted tube designed to transfer excess pleural fluid into the peritoneal cavity to treat, e.g., recurrent pleural effusion. It may require manual pumping.
FDA Product Codes
GBS
Catheter, Ventricular, General & Plastic Surgery
KPM
Shunt, Peritoneal