FDA.report

Gesiva Medical

Primary DI
B598GMLHT0001
Brand
Gesiva Medical
Company
GESIVA MEDICAL LLC
Model
Large High Tension Ring
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

Related Records

Contact Domains

Product Codes

CodeName
LKYDevice, External Penile Rigidity

Product Code Classifications

CodeDeviceSpecialtyClass
LKYDevice, External Penile RigidityGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B598GMLHT0002PackageHIBCC2In Commercial Distribution
B598GMLHT0001PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
866-344-3748info@gesiva.com

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 DIBrandModelCatalogPublished
B598GMXLC00020Gesiva MedicalExtra Large Clear Plastic Cylinder2020-07-17
B598GMTRK0002Gesiva MedicalTension Ring Kit2020-04-09
B598GMMHT0001Gesiva MedicalMedium High Tension Ring2018-01-09
B598GMCC0001Gesiva MedicalCarrying Case2018-01-09
B598GMCI0001Gesiva MedicalComfort Insert2018-01-09
B598GMCPC0001Gesiva MedicalClear Plastic Cylinder2018-01-09
B598GMLST0001Gesiva MedicalLarge Standard Tension Ring2018-01-09
B598GMMST0001Gesiva MedicalMedium Standard Tension Ring2018-01-09
B598GMTRL0001Gesiva MedicalTension Ring Loader2018-01-09
B598GMVPH0001Gesiva MedicalVacuum Pump Handle2018-01-09
B598GMVTS0001Gesiva MedicalVacuum Therapy System2017-10-13

Other Devices Sharing Product Codes

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