Clarity RMS Console

Basic Information

• Brand Name: Clarity RMS Console
• Primary DI: 07290016022025
• Version / Model: ASY00015
• Company Name: RenalSense Ltd.
• Labeler DUNS: 533212192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-02
• Public Version: 1
• Public Version Date: 2019-10-10
• Public Version Status: New
• Public Device Record Key: cc1c5b8e-8bbb-4108-9dac-5f22cc13fd2c

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXY	Uroflowmeter	Gastroenterology, Urology	876.1800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47460	Urine monitoring system monitor	A battery-powered, portable device that automatically and continuously displays urine output data (urine flow/volume) received via a cable from a urine monitoring system's output sensor to provide optimal renal and fluid management information when this is essential to patient care. The monitor typically has controls to allow healthcare staff modify the system settings, electronically stores urine output data, and provides alarms to alert staff to potential problems. It is typically mounted near the patient [e.g., on the patient's bed or an intravenous (IV) pole]. The monitor interconnects with an intensive care unit (ICU) clinical information system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016022025	GS1
Package	17290016022022	GS1	Box	1	In Commercial Distribution
Package	27290016022029	GS1	Master Box	8	In Commercial Distribution