Home GUDID B598GMCC0001 Gesiva Medical
Primary DI B598GMCC0001
Brand Gesiva Medical
Company GESIVA MEDICAL LLC
Model Carrying Case
Published 2018-01-09
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 Code Name LKY Device, External Penile Rigidity
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LKY Device, External Penile Rigidity Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B598GMCC0001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Penile vacuum device A 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.
Regulatory Flags# DUNS number 068245824 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true 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 DI Brand Model Catalog Published B598GMXLC00020 Gesiva Medical Extra Large Clear Plastic Cylinder 2020-07-17 B598GMTRK0002 Gesiva Medical Tension Ring Kit 2020-04-09 B598GMMHT0001 Gesiva Medical Medium High Tension Ring 2018-01-09 B598GMCI0001 Gesiva Medical Comfort Insert 2018-01-09 B598GMCPC0001 Gesiva Medical Clear Plastic Cylinder 2018-01-09 B598GMLHT0001 Gesiva Medical Large High Tension Ring 2018-01-09 B598GMLST0001 Gesiva Medical Large Standard Tension Ring 2018-01-09 B598GMMST0001 Gesiva Medical Medium Standard Tension Ring 2018-01-09 B598GMTRL0001 Gesiva Medical Tension Ring Loader 2018-01-09 B598GMVPH0001 Gesiva Medical Vacuum Pump Handle 2018-01-09 B598GMVTS0001 Gesiva Medical Vacuum Therapy System 2017-10-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850005747079 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747260 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747277 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747284 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747291 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747543 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747550 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747567 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850005747574 Dr. Joel Kaplan Dr. Joel Kaplan, Inc. LKY 2025-04-14 00850002870718 Performance Plus Blush Novelties LKY 2025-03-17 00850002870725 Performance Plus Blush Novelties LKY 2025-03-17 00850002870619 Performance Plus Blush Novelties LKY 2025-02-14 00850002870626 Performance Plus Blush Novelties LKY 2025-02-14 00850002870633 Performance Plus Blush Novelties LKY 2025-02-14 00850002870640 Performance Plus Blush Novelties LKY 2025-02-14 00850002870657 Performance Plus Blush Novelties LKY 2025-02-14 00850002870664 Performance Plus Blush Novelties LKY 2025-02-14 00850002870671 Performance Plus Blush Novelties LKY 2025-02-14 00850002870688 Performance Plus Blush Novelties LKY 2025-02-14 00850002870695 Performance Plus Blush Novelties LKY 2025-02-14 00850002870701 Performance Plus Blush Novelties LKY 2025-02-14 00850002870565 Play With Me Blush Novelties LKY 2024-12-13 00850002870572 Play With Me Blush Novelties LKY 2024-12-13 00850004857113 EDP REACH MEDICAL, INC. LKY 2024-01-18 05060140201113 Bathmate DX PRODUCTS LIMITED LKY 2024-01-01 00850004857106 EDP MAXRC REACH MEDICAL, INC. LKY 2023-12-28 05060140200963 VAXAID DX PRODUCTS LIMITED LKY 2023-10-01 05060140201076 Bathmate DX PRODUCTS LIMITED LKY 2023-10-01 05060140201083 Bathmate DX PRODUCTS LIMITED LKY 2023-10-01 05060140201090 Bathmate DX PRODUCTS LIMITED LKY 2023-10-01
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