Clarity RMS Sensor Tray

GUDID 07290016022056

RenalSense Ltd.

Urine monitoring system sensor
Primary Device ID07290016022056
NIH Device Record Key5adec8e1-4375-4d79-9674-05dca78f59fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameClarity RMS Sensor Tray
Version Model NumberKIT00013
Company DUNS533212192
Company NameRenalSense Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016022056 [Primary]
GS117290016022053 [Package]
Package: Master Box [10 Units]
In Commercial Distribution

FDA Product Code

PPBFoley Catheter Kit (Excludes Hiv Testing)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-10
Device Publish Date2019-10-02

Devices Manufactured by RenalSense Ltd.

07290016022032 - Clarity RMS Power Kit2020-02-06
07290016022025 - Clarity RMS Console2019-10-10
07290016022056 - Clarity RMS Sensor Tray2019-10-10
07290016022056 - Clarity RMS Sensor Tray2019-10-10

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