FDA.reportPublic FDA data

Model 7800EP FRU

Primary DI
00816396023697
Brand
Model 7800EP FRU
Company
IVY BIOMEDICAL SYSTEMS, INC.
Model
Model 7800EP FRU
Catalog number
3300-32-15
Device description
The Ivy Biomedical Model 7800EP is an ECG gating monitor designed to acquire, process, and display patient electrocardiogram (ECG) signals and provide synchronized trigger outputs for use with compatible medical imaging and diagnostic equipment. The device provides ECG monitoring and cardiac synchronization capabilities to support procedures requiring precise timing relative to the patient's cardiac cycle.
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816396023697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816396023697008163960236978163960236970816396023697

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system synchronizerA physiological monitoring unit used as a component of an accelerator system that produces a signal which enables the acceleration path of excited particles, usually electrons, and image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used as a trigger for accelerator system application and artifact reduction, or enhancement of signal-to-noise ratios in various real-time applications.

Regulatory Flags#

DUNS number
109132019
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00816396023680Model 7800EP7800EP3304-41-152026-10-27
00816396022676WGS-100 Respiration Pillow2802-03-012026-08-03
00816396023550WGS-100 Wireless Gating System4162-01-152026-08-03
00816396023567WGS-100 Transmitter3647-02-012026-08-03
00816396023574WGS-100 Base Station4094-02-012026-08-03
00816396022553ECG Patient Cable5904825904822023-06-08
00816396022560ECG Patient Cable5904795904792023-06-08
00816396022577ECG Patient Cable5904805904802023-06-08
00816396022706ECG Patient Cable5904775904772023-06-08
00816396022713ECG Patient Cable5904785904782023-06-08
00816396022812ECG Trunk Cable5904765904762023-06-08
00816396022829ECG Patient Cable5904815904812023-06-08
00816396022836ECG Lead Wires5904915904912023-06-08
00816396022843ECG Lead Wires5904895904892023-06-08
00816396022850ECG Lead Wires5904905904902023-06-08
00816396022911ECG Trunk Cable5904925904922023-06-08
00816396021570ECG Patient Cable5904065904062016-09-01
00816396021587ECG Lead Wires5904075904072016-09-01
00816396021594ECG Patient Cable5904085904082016-09-01
00816396021600ECG Lead Wires5904095904092016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816396023680Model 7800EPIVY BIOMEDICAL SYSTEMS, INC.DRT2026-10-27
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00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDRT2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDRT2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDRT2026-10-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DRT2026-08-26
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
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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