Clarity RMS Console

GUDID 07290016022025

RenalSense Ltd.

Urine monitoring system monitor

• Primary Device ID: 07290016022025
• NIH Device Record Key: cc1c5b8e-8bbb-4108-9dac-5f22cc13fd2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarity RMS Console
• Version Model Number: ASY00015
• Company DUNS: 533212192
• Company Name: RenalSense Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016022025 [Primary]
GS1	17290016022022 [Package]; Package: Box [1 Units]; In Commercial Distribution
GS1	27290016022029 [Package]; Contains: 17290016022022; Package: Master Box [8 Units]; In Commercial Distribution

FDA Product Code

• EXY: Uroflowmeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-10
• Device Publish Date: 2019-10-02

Devices Manufactured by RenalSense Ltd.

• 07290016022032 - Clarity RMS Power Kit: 2020-02-06
• 07290016022025 - Clarity RMS Console: 2019-10-10
• 07290016022025 - Clarity RMS Console: 2019-10-10
• 07290016022056 - Clarity RMS Sensor Tray: 2019-10-10