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Automatic Continuous Effusion Shunt (ACES) System AS16-7

by Pleural Dynamics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860011648109 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Automatic Continuous Effusion Shunt (ACES) System
Generic Name
Pleuroperitoneal shunt
Model / Ref / Catalog
AS16-7, AS16-7-1
Primary DI / UDI-DI
00860011648109
FDA Product Code
GBS, KPM
GMDN Term
Pleuroperitoneal shunt
Device Class
Class I
Regulation Number
878.4200, 876.5955
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Pleural Dynamics, Inc.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No