Model 7800 3304-22-15

GUDID 00816396020634

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

X-ray system synchronizer X-ray system synchronizer X-ray system synchronizer
Primary Device ID00816396020634
NIH Device Record Key15b1ef2f-98c0-48b8-ae38-b87463abd5a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7800
Version Model Number3304-22-15
Catalog Number3304-22-15
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

Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch
Height8.72 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100816396020634 [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 7800]

00816396022423Cardiac Gating Module
00816396022416Cardiac Gating Module
00816396022409Cardiac Gating Module
00816396022393Cardiac Gating Module
00816396022386Cardiac Gating Monitor & Accessory Kit
00816396022379Cardiac Gating Monitor & Accessory Kit
00816396022362Cardiac Gating Monitor & Accessory Kit
00816396022355Cardiac Gating Module
00816396022218Cardiac Gating Module
00816396022201Cardiac Gating Monitor & Accessory Kit
00816396022126Cardiac Gating Module
00816396021525Cardiac Gating Module
00816396021389Cardiac Gating Module
00816396021372Cardiac Gating Module
00816396021365Cardiac Gating Module
00816396021358Cardiac Gating Module
00816396021341Cardiac Gating Module
00816396021334Cardiac Gating Module
00816396021327Cardiac Gating Module
00816396021310Cardiac Gating Module
00816396021303Cardiac Gating Module
00816396021297Cardiac Gating Module
00816396021280Cardiac Gating Module
00816396021273Cardiac Gating Module
00816396021266Cardiac Gating Module
00816396021259Cardiac Gating Module
00816396021242Cardiac Gating Module
00816396021235Cardiac Gating Module
00816396021228Cardiac Gating Module
00816396020726Cardiac Gating Monitor & Accessory Kit
00816396020719Cardiac Gating Monitor & Accessory Kit
00816396020702Cardiac Gating Monitor & Accessory Kit
00816396020696Cardiac Gating Monitor & Accessory Kit
00816396020689Cardiac Gating Monitor & Accessory Kit
00816396020672Cardiac Gating Monitor & Accessory Kit
00816396020665Cardiac Gating Monitor & Accessory Kit
00816396020658Cardiac Gating Monitor & Accessory Kit
00816396020641Cardiac Gating Monitor & Accessory Kit
00816396020634Cardiac Gating Monitor & Accessory Kit
00816396020627Cardiac Gating Monitor & Accessory Kit
00816396020610Cardiac Gating Monitor & Accessory Kit
00816396020603Cardiac Gating Monitor & Accessory Kit
00816396020597Cardiac Gating Monitor & Accessory Kit
00816396020580Cardiac Gating Monitor & Accessory Kit
00816396020573Cardiac Gating Monitor & Accessory Kit
00816396020566Cardiac Gating Monitor & Accessory Kit
00816396020559Cardiac Gating Monitor & Accessory Kit
00816396020542Cardiac Gating Monitor & Accessory Kit
00816396020535Cardiac Gating Monitor & Accessory Kit
00816396020528Cardiac Gating Monitor & Accessory Kit

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