FDA.reportPublic FDA data

Bathmate

Primary DI
05060140201021
Brand
Bathmate
Company
DX PRODUCTS LIMITED
Model
Hydromax 8 CC
Catalog number
BM-HM8-CC
Device description
Bathmate Hydromax 8 Crystal Clear
Published
2023-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
05060140201083PackageGS110In Commercial Distribution
05060140201021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060140201083050601402010835060140201083
05060140201021050601402010215060140201021

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth8Inch
Lumen/Inner Diameter3Inch

Contacts#

Phone, Email table
PhoneEmail
+448008085594support@bathmatedirect.com

Regulatory Flags#

DUNS number
216732051
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060140201106BathmateHydroXtreme 8 BM-HX8-CC2024-01-01
05060140201113BathmateHydroXtreme 8 BM-HX8-CC2024-01-01
05060140200895VAXAIDV3 DELUXEVX-V3-D2023-10-01
05060140201014BathmateHydromax 8 ABBM-HM8-AB2023-10-01
05060140201038BathmateHydromax 8 BRBM-HM8-BR2023-10-01
05060140200963VAXAIDV3 DELUXEVX-V3-D2023-10-01
05060140201076BathmateHydromax 8 ABBM-HM8-AB2023-10-01
05060140201083BathmateHydromax 8 CCBM-HM8-CC2023-10-01
05060140201090BathmateHydromax 8 BRBM-HM8-BR2023-10-01
05060140208440VaxaidVaxaid V5 DeluxVX-V5-D2019-03-01
05060140208488VaxaidVaxaid V7 DeluxVX-V7-D2019-03-01
05060140208501VaxaidVaxaid V7 TrainerVX-V7-T2019-03-01
05060140208525VaxaidVaxaid V9 DeluxVX-V9-D2019-03-01
05060140208419VaxaidPeyronie's DiseaseVX-V7WB-D2021-03-01
05060140209201BathmateHydromax 3 Brilliant RedBM-HM3-BR2021-03-01
05060140209195BathmateHydromax 3 Aqua BlueBM-HM3-AB2021-03-01
05060140200871BathmateHydromax 3 Brilliant RedBM-HM3-BR2021-03-01
05060140209218BathmateHydromax 3 Crystal ClearBM-HM3-CC2021-03-01
05060140208297BathmateHydro 5 Brilliant RedBM-H5-BR2020-04-01
05060140208303BathmateHydro 5 Crystal ClearBM-H5-CC2020-04-01

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