FDA.reportPublic FDA data

Model 7600EP

Primary DI
00816396023079
Brand
Model 7600EP
Company
IVY BIOMEDICAL SYSTEMS, INC.
Model
3299-42-15
Catalog number
3299-42-15
Device description
Cardiac Gating Module
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K202138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202138000Cardiac Trigger MonitorIvy Biomedical Systems, Inc.2021-05-14DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816396023079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816396023079008163960230798163960230790816396023079

GMDN Terms#

Term, Definition table
TermDefinition
Nuclear medicine system synchronizerA physiological monitoring unit used a component of a diagnostic nuclear medicine imaging system, e.g., single photon emission computed tomography (SPECT), positron emission tomography (PET) or gamma camera, that produces a signal which enables 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 for the purpose of artifact reduction or enhancement of signal-to-noise ratios in various real-time or dynamic nuclear medicine imaging applications. It is sometimes referred to as a gated imaging accessory or trigger.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth5.18Inch
Height7.49Inch
Weight3.9Pound
Width7.94Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-481-4183sales@ivybiomedical.com

Regulatory Flags#

DUNS number
109132019
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816396021617ECG Patient Cable5904105904102016-09-01
00816396021624ECG Lead Wires5904115904112016-09-01
00816396021631ECG Patient Cable5904125904122016-09-01
00816396021648ECG Lead Wires5904135904132016-09-01
00816396021655ECG Snap Lead Wires5904145904142016-09-01

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