Rapport - Vacuum Therapy Device

FDA UDI

Class II (US FDA UDI)

by Owen Mumford Usa Incorporated

Identity

Trade Name: Rapport - Vacuum Therapy Device FDA UDI
Generic Name: Penile vacuum device FDA UDI
Device Name: A non-sterile, reusable vacuum therapy impotence management system. FDA UDI
Model / Reference: SM 2000 FDA UDI
Description: A non-sterile, reusable vacuum therapy impotence management system. FDA UDI

Identifiers

Primary DI / UDI-DI: 00384702000019 FDA UDI
FDA Product Code: LKY FDA UDI
GMDN Term: Penile vacuum device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 67 Millimeter FDA UDI
Length — 220 Millimeter FDA UDI

Category: Penile vacuum device

Rapport - Vacuum Therapy Device by Owen Mumford Usa Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Owen Mumford Usa Incorporated

Sources (1)

FDA UDI 839c4a98-a79b-485b-9f91-8cdffe8b5112 36 fields · synced May 31, 2026