Gesiva Medical

Basic Information

• Brand Name: Gesiva Medical
• Primary DI: B598GMMHT0001
• Version / Model: Medium High Tension Ring
• Company Name: GESIVA MEDICAL LLC
• Labeler DUNS: 068245824
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-09
• Public Version: 3
• Public Version Date: 2018-04-27
• Public Version Status: Update
• Public Device Record Key: 52ec4683-f49c-44eb-bce5-10f6c780cf0b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	876.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17744	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B598GMMHT0001	HIBCC
Package	B598GMMHT0002	HIBCC		2	In Commercial Distribution
Package	B598GMTRK0001	HIBCC		1	Not in Commercial Distribution	2018-04-26

Customer Contacts

• Phone: [phone]
• Email: [email protected]