FDA.reportPublic FDA data

Pos-T-Vac

Primary DI
00656535000628
Brand
Pos-T-Vac
Company
POS-T-VAC INC
Model
Mach 1 Ring 5
Catalog number
A141
Published
2018-08-28
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
00656535000628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00656535000628006565350006286565350006280656535000628

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
186548160
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00656535000949Pos-T-VacRing LoaderK1172018-09-21
00656535000284Pos-T-VacSustainB2412018-08-30
00656535000437Pos-T-VacBushing AJ1012018-08-30
00656535000444Pos-T-VacBushing BJ1022018-08-30
00656535000451Pos-T-VacBushing CJ1032018-08-30
00656535000482Pos-T-VacTwist Lock TubeK1012018-08-30
00656535000499Pos-T-VacTube SlipV1062018-08-31
00656535000505Pos-T-VacBushing SlipV107L2018-08-31
00656535000512Pos-T-VacBushing SmallV107S2018-08-31
00656535000529Pos-T-VacCone GreyV1142018-08-31
00656535000536Pos-T-VacCone WhiteJ1102018-08-30
00656535000673Pos-T-VacBOS-2000-3 Twist Pump HeadB2382018-08-30
00656535000703Pos-T-VacIVP-600 Pump HeadI1552018-08-30
00656535000765Pos-T-VacAVP-1000/BOS-2000-3 (Slip)A10002018-08-30
00656535000772Pos-T-VacPTV Automatic 3000/BOS-2000-3 (Slip)B2292018-08-30
00656535000789Pos-T-VacBOS-2000-3 Twist SystemB2392018-08-30
00656535000796Pos-T-VacBOS-2000-3 Twist Basic SystemB2422018-08-30
00656535000802Pos-T-VacBOS-2000-2 Slip Pump HeadB2512018-08-30
00656535000819Pos-T-VacPTV Automatic 2000/BOS-2000-2 SlipB2522018-08-30
00656535000826Pos-T-Vac"Scrotal Shield 3/4"""J113-3/42018-08-30

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