FDA.reportPublic FDA data

CIRCA Temperature Monitoring System

Primary DI
00851498007152
Brand
CIRCA Temperature Monitoring System
Company
CIRCA Scientific, Inc.
Model
CS-1000 (SW Ver 3.0)
Published
2023-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222311000CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, Inc.2023-05-25FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851498007152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851498007152008514980071528514980071520851498007152

GMDN Terms#

Term, Definition table
TermDefinition
Continuous electronic patient thermometer, line-poweredA mains electricity (AC-powered) electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963223222
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860237000207S-CATH™ Esophageal Temperature ProbeCS-27ST (Straight)2019-03-25
10860237000214S-CATH™ Esophageal Temperature ProbeCS-2001 (65cm Length)2016-09-23
10860237000238S-CATH™ Esophageal Temperature ProbeCS-2007 (65cm Length)2016-09-23
10860237000245S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23
30860237000218S-CATH™ Esophageal Temperature ProbeCS-2001 (65cm Length)2016-09-23
30860237000232S-CATH™ Esophageal Temperature ProbeCS-2007 (65cm Length)2016-09-23
30860237000249S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23
10851498007395PeriCross Epicardial Access KitPC-10132025-07-23
10851498007432CrossWise RF Transseptal SystemCW-1085C2025-05-28
10851498007449CrossWise RF Transseptal SystemCW-1085V2025-05-28
10851498007456CrossWise RF Transseptal SystemCW-1013F2025-05-28
00851498007404CIRCA Temperature Monitoring SystemCS-1000 (SW Ver 3.2)2025-02-14
10851498007333CrossWise RF Transseptal SystemCW-1085S2024-12-02
10851498007340CrossWise RF Transseptal SystemCW-1085A2024-12-02
10851498007357CrossWise RF Transseptal SystemCW-1012W2024-12-02
10851498007364CrossWise RF Transseptal SystemCW-1012C2024-12-02
10851498007371CrossWise Multi-Use RF Adapter CableCW-10012024-12-02
00851498007381CIRCA Temperature Monitoring SystemCS-1000 (SW Ver 3.1)2024-10-31
10851498007197CardioCurve Steerable SheathCC-1040S2024-08-01
10851498007203CardioCurve Steerable SheathCC-1040M2024-08-01

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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22