Model 7600EP 3303-47-15

GUDID 00816396022898

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

Nuclear medicine system synchronizer
Primary Device ID00816396022898
NIH Device Record Key8d7e5c0e-1154-4e94-96de-4e0afd2856e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7600EP
Version Model Number3303-47-15
Catalog Number3303-47-15
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
GS100816396022898 [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 7600EP]

00816396023222Cardiac Gating Monitor & Accessory Kit
00816396023215Cardiac Gating Monitor & Accessory Kit
00816396023208Cardiac Gating Module
00816396022928Cardiac Gating Monitor & Accessory Kit
00816396022904Cardiac Gating Monitor & Accessory Kit
00816396022898Cardiac Gating Monitor & Accessory Kit
00816396021495Cardiac Gating Monitor & Accessory Kit
00816396023079Cardiac Gating Module
00816396022881Cardiac Gating Module
00816396022874Cardiac Gating Module
00816396022867Cardiac Gating Module

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