FDA.reportPublic FDA data

Performance Plus

Primary DI
00850002870664
Brand
Performance Plus
Company
Blush Novelties
Model
Performance Plus - Drift - Black
Catalog number
BL-92035
Device description
Performance Plus - Drift - BlackPart Number: BL-92035Material: Silicone
Published
2025-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002870664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002870664008500028706648500028706640850002870664

GMDN Terms#

Term, Definition table
TermDefinition
Penile ringA device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057027601
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002870800BlushBlush Lube - Water-Based - 4 FL Oz.BL-100492025-09-26
00850002870718Performance PlusPerformance Plus - Flex Pro - BlueBL-900022025-03-17
00850002870725Performance PlusPerformance Plus - Dual Flex Pro - BlueBL-900122025-03-17
00810138370834DeliceDelice - Chéri - Kegel Trainer - PurpleBL-237212025-03-13
00850002870619Performance PlusPerformance Plus - Throttle - BlackBL-920052025-02-14
00850002870626Performance PlusPerformance Plus - Engage - Black / BlueBL-920022025-02-14
00850002870633Performance PlusPerformance Plus - Accelerate - BlackBL-920152025-02-14
00850002870640Performance PlusPerformance Plus - Pursuit - RedBL-920082025-02-14
00850002870657Performance PlusPerformance Plus - Traction - BlackBL-920252025-02-14
00850002870671Performance PlusPerformance Plus - Flash - MultiBL-920222025-02-14
00850002870688Performance PlusPerformance Plus - Takeoff - Red/BlackBL-922222025-02-14
00850002870695Performance PlusPerformance Plus - Flare - Black / NeonckBL-923222025-02-14
00850002870701Performance PlusPerformance Plus - Launch - BlackBL-920452025-02-14
00819835024125WellnessWellness - Kegel Training Kit - PurpleBL-4440042025-01-28
00850002870565Play With MePlay With Me - Pleaser Rechargeable C-Ring - Neon BL-316222024-12-13
00850002870572Play With MePlay With Me - Pleaser Rechargeable C-Ring - PinkBL-316102024-12-13
00819835023425WellnessWellness - Dilator Kit - PurpleBL-4441112023-08-17
00853858007383Stay HardStay Hard - Beaded Cock Rings - BlackBL-000152022-12-06
00853858007451Stay HardStay Hard - Donut Rings - 50 Piece Display EditBC-0082022-12-06
00853858007611Play With MePlay With Me - Stretch C-Ring - 50 piecesBC-0092022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076064006Pump Worx Beginner's Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064013Pump Worx Max Boost - White PD Products, LLCLKY2026-05-01
00850076064020Max Boost Pro Flow - Blue/Clear PD Products, LLCLKY2026-05-01
00850076064037Pipedream Beginner's Power Pump - Black PD Products, LLCLKY2026-05-01
00850076064044Pump Worx Max Boost - Black PD Products, LLCLKY2026-05-01
00850076064051Pipedream Beginner's Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064068Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064075Max Boost Pro Flow - White/Clear PD Products, LLCLKY2026-05-01
00850076064082Pump Worx Accu-Meter Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064099Pump Worx Rookie of the Year Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064105Pump Worx Max Boost - Blue PD Products, LLCLKY2026-05-01
00850076064112Pump Worx Silicone Power Pump - Blue PD Products, LLCLKY2026-05-01
00850076064129Pump Worx Silicone Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064136Pump Worx Beginner's Power Pump - Purple PD Products, LLCLKY2026-05-01
00850076064143Pump Worx Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850076064150Classix Power PumpPD Products, LLCLKY2026-05-01
00850076064167Pump Worx Beginner's Power Pump - Red PD Products, LLCLKY2026-05-01
00850076064174Classix Vibrating Power Pump - ClearPD Products, LLCLKY2026-05-01
00850076064181Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLCLKY2026-05-01
00850076064198Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLCLKY2026-05-01
00850076064204Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLCLKY2026-05-01
00850076064211Pipedream Beginner's Power Pump - Clear PD Products, LLCLKY2026-05-01
00850005747079Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747260Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747277Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747284Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747291Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747543Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747550Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850005747567Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14