Rapport - Vacuum Therapy Device SM2000

GUDID 00384702000019

Penile vacuum device

Primary Device ID	00384702000019
NIH Device Record Key	839c4a98-a79b-485b-9f91-8cdffe8b5112
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rapport - Vacuum Therapy Device
Version Model Number	SM2000
Catalog Number	SM2000
Company DUNS	803401454
Company Name	OWEN MUMFORD USA INCORPORATED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	true

Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00384702000019 [Primary]
GS1	00384702000033 [Package] Package: Case [5 Units] In Commercial Distribution

LKY	Device, External Penile Rigidity

Steralize Prior To Use	false
Device Is Sterile	false

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