AccessGUDID - DEVICE: Rapport - Vacuum Therapy Device (00384702000019)

GUDID

Device Identifier (DI) Information

Brand Name: Rapport - Vacuum Therapy Device
Version or Model: SM 2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWEN MUMFORD USA INCORPORATED

Primary DI Number: 00384702000019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 803401454 *Terms of Use

Device Description: A non-sterile, reusable vacuum therapy impotence management system.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKY	Device, External Penile Rigidity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Width: 67 Millimeter
Length: 220 Millimeter

Device Record Status

Public Device Record Key: 839c4a98-a79b-485b-9f91-8cdffe8b5112
Public Version Date: March 24, 2022
Public Version Number: 3
DI Record Publish Date: September 19, 2016