Rapport - Vacuum Therapy Device SM2000

GUDID 00384702000019

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

OWEN MUMFORD USA INCORPORATED

Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device Penile vacuum device
Primary Device ID00384702000019
NIH Device Record Key839c4a98-a79b-485b-9f91-8cdffe8b5112
Commercial Distribution StatusIn Commercial Distribution
Brand NameRapport - Vacuum Therapy Device
Version Model NumberSM2000
Catalog NumberSM2000
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Length220 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter
Width67 Millimeter
Length220 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384702000019 [Primary]
GS100384702000033 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

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