Home GUDID 00888912196475 BELL-HORN
Primary DI 00888912196475
Brand BELL-HORN
Company DJO, LLC
Model 10400
Device description ENCORE REVIVE VAC THERP SYSTEM
Published 2016-09-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
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 00888912196475 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 00888912196475 00888912196475 888912196475 0888912196475
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 081840873 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false 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 true Sterilization required before use false Other Devices From This Company# 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