FDA.reportPublic FDA data

CIRCA Temperature Standard

Primary DI
00851498007176
Brand
CIRCA Temperature Standard
Company
CIRCA Scientific, Inc.
Model
CS-104
Published
2023-06-30
Public version status
Update
Distribution status
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
00851498007176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851498007176008514980071768514980071760851498007176

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable testerA non-powered device intended to be used to test the electrical continuity of an electrical-only medical device connection cable, which connects two medical devices (e.g., transducer and monitor). The tester is attached to one end of the cable to modulate the signal created, and then displayed/recorded, by one of the devices. It is intended to be used by a healthcare provider in a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963223222
Device count
1
Lot or batch
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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Primary DI, Brand, Company table
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.FLL2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22