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Elite Custom Plus Battery Vacuum Pump

by Augusta Medical Systems, L.L.C.

Elite Custom Plus Battery Vacuum Pump is a Class II device made by Augusta Medical Systems, L.L.C., listed in FDA GUDID since 17 Jul 2017 (UDI-DI 00852598007073), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852598007073 UDI-DI Date17 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Elite Custom Plus
Generic name
Penile vacuum device
Model / reference
Battery Vacuum Pump
Primary DI / UDI-DI
00852598007073
FDA product code
LKY
GMDN term
Penile vacuum device
Device class
Class II
Regulation number
876.5020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Penile vacuum device

Similar devices

Other devices filed under FDA product code LKY (Device, External Penile Rigidity).

Other devices from Augusta Medical Systems, LLC

See all devices from Augusta Medical Systems, LLC →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)