Clarity RMS Sensor Tray

Basic Information

• Brand Name: Clarity RMS Sensor Tray
• Primary DI: 07290016022056
• Version / Model: KIT00013
• 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: 5adec8e1-4375-4d79-9674-05dca78f59fc

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPB	Foley Catheter Kit (Excludes Hiv Testing)	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47461	Urine monitoring system sensor	An electronic device (e.g., an optical reader) that automatically and continuously measures a patient's urine output (urine flow/volume) in a urine monitoring system's collection container. The sensor subsequently transmits urine output data, via a cable, to the system's monitor for display and electronic storage. It may be mounted on the patient's bed or an intravenous (IV) pole, and may be designed to support the urine collection container.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016022056	GS1
Package	17290016022053	GS1	Master Box	10	In Commercial Distribution