Home GUDID 00850004857045 EDP
Primary DI 00850004857045
Brand EDP
Company REACH MEDICAL, INC.
Model EDP-MOS
Catalog number EDP-MOS
Device description External Penile Rigidity Device Manually Operated
Published 2019-12-31
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true 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 00850004857045 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850004857045 00850004857045 850004857045 0850004857045
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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -40 Degrees Celsius 70 Degrees Celsius
Regulatory Flags# DUNS number 127526064 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850076064006 Pump Worx Beginner's Power Pump - Blue PD Products, LLC LKY 2026-05-01 00850076064013 Pump Worx Max Boost - White PD Products, LLC LKY 2026-05-01 00850076064020 Max Boost Pro Flow - Blue/Clear PD Products, LLC LKY 2026-05-01 00850076064037 Pipedream Beginner's Power Pump - Black PD Products, LLC LKY 2026-05-01 00850076064044 Pump Worx Max Boost - Black PD Products, LLC LKY 2026-05-01 00850076064051 Pipedream Beginner's Power Pump - Blue PD Products, LLC LKY 2026-05-01 00850076064068 Pump Worx Beginner's Vibrating Pump - Clear/Black PD Products, LLC LKY 2026-05-01 00850076064075 Max Boost Pro Flow - White/Clear PD Products, LLC LKY 2026-05-01 00850076064082 Pump Worx Accu-Meter Power Pump - Clear/Black PD Products, LLC LKY 2026-05-01 00850076064099 Pump Worx Rookie of the Year Pump - Clear/Black PD Products, LLC LKY 2026-05-01 00850076064105 Pump Worx Max Boost - Blue PD Products, LLC LKY 2026-05-01 00850076064112 Pump Worx Silicone Power Pump - Blue PD Products, LLC LKY 2026-05-01 00850076064129 Pump Worx Silicone Power Pump - Clear/Black PD Products, LLC LKY 2026-05-01 00850076064136 Pump Worx Beginner's Power Pump - Purple PD Products, LLC LKY 2026-05-01 00850076064143 Pump Worx Beginner's Power Pump - Clear PD Products, LLC LKY 2026-05-01 00850076064150 Classix Power Pump PD Products, LLC LKY 2026-05-01 00850076064167 Pump Worx Beginner's Power Pump - Red PD Products, LLC LKY 2026-05-01 00850076064174 Classix Vibrating Power Pump - Clear PD Products, LLC LKY 2026-05-01 00850076064181 Pump Worx Beginner's Power Pump - Smoke/Black PD Products, LLC LKY 2026-05-01 00850076064198 Pump Worx Pistol-Grip Power Pump - Clear/Black PD Products, LLC LKY 2026-05-01 00850076064204 Pump Worx Max-Width Penis Enlarger - Clear/Black PD Products, LLC LKY 2026-05-01 00850076064211 Pipedream Beginner's Power Pump - Clear PD Products, LLC LKY 2026-05-01 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
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