Model 7600 3303-06-15

GUDID 00816396020054

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer
Primary Device ID00816396020054
NIH Device Record Key8afe14ab-de0d-43bd-a9df-5c67757dc65c
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7600
Version Model Number3303-06-15
Catalog Number3303-06-15
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 Producttrue
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

Device Dimensions

Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch
Height7.49 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100816396020054 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [Model 7600]

00816396022461Cardiac Gating Module
00816396022454Cardiac Gating Monitor & Accessory Kit
00816396022249Cardiac Gating Monitor & Accessory Kit
00816396022232Cardiac Gating Monitor & Accessory Kit
00816396022119Cardiac Gating Module
00816396021983Cardiac Gating Monitor & Accessory Kit
00816396021976Cardiac Gating Module
00816396021952Cardiac Gating Module
00816396021945Cardiac Gating Module
00816396021938Cardiac Gating Module
00816396021518Cardiac Gating Module
00816396021488Cardiac Gating Module
00816396021471Cardiac Gating Monitor & Accessory Kit
00816396021198Cardiac Gating Module
00816396021181Cardiac Gating Module
00816396021174Cardiac Gating Module
00816396021167Cardiac Gating Module
00816396021150Cardiac Gating Module
00816396021143Cardiac Gating Module
00816396021136Cardiac Gating Module
00816396021129Cardiac Gating Module
00816396021112Cardiac Gating Module
00816396021105Cardiac Gating Module
00816396021099Cardiac Gating Module
00816396021082Cardiac Gating Module
00816396021075Cardiac Gating Module
00816396021068Cardiac Gating Module
00816396021051Cardiac Gating Module
00816396021044Cardiac Gating Module
00816396021037Cardiac Gating Module
00816396021020Cardiac Gating Module
00816396021013Cardiac Gating Module
00816396021006Cardiac Gating Module
00816396020993Cardiac Gating Module
00816396020986Cardiac Gating Module
00816396020979Cardiac Gating Module
00816396020962Cardiac Gating Module
00816396020955Cardiac Gating Module
00816396020948Cardiac Gating Module
00816396020375Cardiac Gating Monitor & Accessory Kit
00816396020368Cardiac Gating Monitor & Accessory Kit
00816396020351Cardiac Gating Monitor & Accessory Kit
00816396020344Cardiac Gating Monitor & Accessory Kit
00816396020337Cardiac Gating Monitor & Accessory Kit
00816396020320Cardiac Gating Monitor & Accessory Kit
00816396020313Cardiac Gating Monitor & Accessory Kit
00816396020306Cardiac Gating Monitor & Accessory Kit
00816396020290Cardiac Gating Monitor & Accessory Kit
00816396020283Cardiac Gating Monitor & Accessory Kit
00816396020276Cardiac Gating Monitor & Accessory Kit

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