CIRCA Temperature Monitoring System

GUDID 00851498007046

CIRCA SCIENTIFIC, LLC

Continuous electronic patient thermometer, line-powered
Primary Device ID00851498007046
NIH Device Record Keyb5cbeb9e-f2aa-45b0-aa3b-ead339d525d0
Commercial Distribution Discontinuation2017-07-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCIRCA Temperature Monitoring System
Version Model NumberCS-1000
Company DUNS963223222
Company NameCIRCA SCIENTIFIC, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851498007046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [CIRCA Temperature Monitoring System]

00851498007077CS-1000 (S/W Version 2.1)
00851498007046CS-1000
00851498007121CS-1000
00851498007152CS-1000 (SW Ver 3.0)
00851498007145CS-1000 (SW Ver 2.1, MATRIX12)

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