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Performance

by Blush Novelties 34 variants

Performance (BL-09401) is a Class II device made by Blush Novelties, listed in FDA GUDID since 29 Oct 2019 (UDI-DI 00850002870077), registry data as of 31 May 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 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850002870077 UDI-DI Date29 Oct 2019ListedStatusListed 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  • Withdrawn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

Generic name
Penile vacuum device
Model / Ref / Catalog
Gauge Pump Trigger With Silicone Tubing and Silicone Cock Strap - Black, BL-09401
Description
The Pump comes with an airtight chamber, advanced trigger pump, a soft pump sleeve and cock strap.Accessory item number BL-09401 Material silicone, ABS
Primary DI / UDI-DI
00850002870077
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 Blush Novelties

See all devices from Blush Novelties →

Properties

  • Over-the-counter
  • Premarket exempt
Other properties (13, all answered No)