Model 7800EP 3300-28-15

GUDID 00816396022935

Cardiac Gating Module

IVY BIOMEDICAL SYSTEMS, INC.

Nuclear medicine system synchronizer
Primary Device ID00816396022935
NIH Device Record Key764429a7-d2ee-4b3e-a8ab-746ceed99ae5
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7800EP
Version Model Number3300-28-15
Catalog Number3300-28-15
Company DUNS109132019
Company NameIVY BIOMEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com
Phone203-481-4183
Emailsales@ivybiomedical.com

Device Dimensions

Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound
Height7.49 Inch
Width7.94 Inch
Depth5.18 Inch
Weight3.9 Pound

Device Identifiers

Device Issuing AgencyDevice ID
GS100816396022935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [Model 7800EP]

00816396023086Cardiac Gating Module
00816396023062Cardiac Gating Module
00816396022935Cardiac Gating Module

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