Mediplus

Basic Information

• Brand Name: Mediplus
• Primary DI: 05055140701633
• Version / Model: 3651
• Company Name: MEDIPLUS LTD
• Labeler DUNS: 228480810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 609ae480-eb0a-48b4-bd66-1c113bdbe0f4

Device Description

38mm penile cuff 1m lead

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEN	DEVICE, CYSTOMETRIC, HYDRAULIC	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58265	Male urinary outflow analysis system cuff	A non-sterile inflatable cuff that is a component of a male urinary outflow analysis system. It is intended to be attached around the penis and inflated/deflated according to a software program while the patient is urinating to provide data that can be used to help diagnose lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO) in men. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15055140701630	GS1		25	In Commercial Distribution
Primary	05055140701633	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	38.0	Millimeter