FDA.reportPublic FDA data

S-CATH™ Esophageal Temperature Probe

Primary DI
30860237000218
Brand
S-CATH™ Esophageal Temperature Probe
Company
CIRCA Scientific, Inc.
Model
CS-2001 (65cm Length)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K112376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112376000S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEMCirca Scientific, LLC2011-08-31FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860237000211PackageGS15In Commercial Distribution
30860237000218PackageGS110In Commercial Distribution
10860237000214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086023700021120860237000211
3086023700021830860237000218
1086023700021410860237000214

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient temperature probe, single-useA temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963223222
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
10851498007210CardioCurve Steerable SheathCC-1040L2024-08-01

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