FDA.reportPublic FDA data

ProSim 2

Primary DI
00850540007089
Brand
ProSim 2
Company
FLUKE ELECTRONICS CORPORATION
Model
PROSIM 2
Catalog number
4318341
Device description
Vital Signs Patient Simulator
Published
2018-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110429000PROSIM 4, PROSIM 6, PROSIM 8Fluke Biomedical2011-09-02DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850540007089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850540007089008505400070898505400070890850540007089

GMDN Terms#

Term, Definition table
TermDefinition
Multi-parameter device testerA battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002687614
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850540007133Impulse 4000IMPULSE4K-USA120V22471572018-05-24
00850540007157SigmaPace 1000SIGMAP1K-USA120V22477002018-05-24
00850540007188DPM1BDPM1B22497792018-05-24
00850540007225ProSim 8PPROSIM 8P60217062025-05-07
00850540007195BP Pump 2LBPPUMP2L-US120V22490362018-05-24
00850540007201BP Pump 2MBPPUMP2M-US120V22490492018-05-24
00850540007218ESA 614ESA61450319182019-04-04
00850540007065ProSim 8PROSIM 839794092018-05-24
00850540007072ProSim 4PROSIM 439851562018-05-24
00850540007096ProSim 3PROSIM 343077902018-05-24
00850540007102ProSim SPOT LightSPOT LIGHT41111012018-05-24
00850540007119Impulse 6000DIMPULSE 6000D28119282018-05-24
00850540007140Impulse 7010IMPULSE 701031585442018-05-24
00850540007164PS320PS32025830302018-05-24
00850540007171PS410PS41026312762018-05-24
00850540007010ESA 620ESA62027857252018-05-24
00850540007027ESA 615ESA615-US41320462018-05-24
00850540007034ESA 615ESA615-10-NA22041321642018-05-24
00850540007041ESA 612ESA612-US41321732018-05-24
00850540007058ESA 612ESA612-10-NA22041322602018-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDRT2026-04-15
08809988780049Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)Xandar Kardian Korea Inc.DRT2025-12-04
00850005949671BioButton Charging StationBIOINTELLISENSE, INC.DRT2025-11-19
00856298006343Aermos softwareScottCare Cardiovascular SolutionsDRT2025-10-28
00856298006381Aermos Tx DeviceScottCare Cardiovascular SolutionsDRT2025-10-28
00856298006411AermosSCOTTCARE CORPORATION, THEDRT2025-10-28
00856298006442Aermos Tx Patiet CableScottCare Cardiovascular SolutionsDRT2025-10-28
00850005949466BioDashboardBIOINTELLISENSE, INC.DRT2025-02-28
00850005949596BioButton Charging StationBIOINTELLISENSE, INC.DRT2025-02-19