FDA.reportPublic FDA data

BLUSH PERFORMANCE VX5

Primary DI
00853858007222
Brand
BLUSH PERFORMANCE VX5
Company
Blush Novelties
Model
PERFORMANCE VX5
Catalog number
BL-09037
Device description
Male Enhancement Pump System Part Number: BL-09037
Published
2017-12-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00853858007222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853858007222008538580072228538580072220853858007222

GMDN Terms#

Term, Definition table
TermDefinition
Penile vacuum deviceA device that is applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is typically a two-component device consisting of: 1) a manually-operated, vacuum pump/sleeve which is applied over the flaccid penis and used to create a vacuum to achieve tumescence through an up and down movement along a vacuum tube; and 2) a constriction ring used in conjunction with the pump and placed upon the penis to maintain the erection. The ring remains on the penis for a recommended period of time. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
057027601
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850002870664Performance PlusPerformance Plus - Drift - BlackBL-920352025-02-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850005747574Dr. Joel KaplanDr. Joel Kaplan, Inc.LKY2025-04-14
00850002870718Performance PlusBlush NoveltiesLKY2025-03-17
00850002870725Performance PlusBlush NoveltiesLKY2025-03-17
00850002870619Performance PlusBlush NoveltiesLKY2025-02-14
00850002870626Performance PlusBlush NoveltiesLKY2025-02-14
00850002870633Performance PlusBlush NoveltiesLKY2025-02-14
00850002870640Performance PlusBlush NoveltiesLKY2025-02-14
00850002870657Performance PlusBlush NoveltiesLKY2025-02-14
00850002870664Performance PlusBlush NoveltiesLKY2025-02-14
00850002870671Performance PlusBlush NoveltiesLKY2025-02-14
00850002870688Performance PlusBlush NoveltiesLKY2025-02-14
00850002870695Performance PlusBlush NoveltiesLKY2025-02-14
00850002870701Performance PlusBlush NoveltiesLKY2025-02-14
00850002870565Play With MeBlush NoveltiesLKY2024-12-13
00850002870572Play With MeBlush NoveltiesLKY2024-12-13
00850004857113EDP REACH MEDICAL, INC.LKY2024-01-18
05060140201113BathmateDX PRODUCTS LIMITEDLKY2024-01-01
00850004857106EDP MAXRCREACH MEDICAL, INC.LKY2023-12-28
05060140200963VAXAIDDX PRODUCTS LIMITEDLKY2023-10-01
05060140201076BathmateDX PRODUCTS LIMITEDLKY2023-10-01
05060140201083BathmateDX PRODUCTS LIMITEDLKY2023-10-01
05060140201090BathmateDX PRODUCTS LIMITEDLKY2023-10-01