Model 7700 3607-00-15

GUDID 00816396020382

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

X-ray system synchronizer X-ray system synchronizer X-ray system synchronizer
Primary Device ID00816396020382
NIH Device Record Key5f3c934a-0dff-4420-8023-706fc535e39f
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 7700
Version Model Number3607-00-15
Catalog Number3607-00-15
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 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch
Height7 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100816396020382 [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 Date2016-10-14

On-Brand Devices [Model 7700]

00816396022447Cardiac Gating Module
00816396022430Cardiac Gating Monitor & Accessory Kit
00816396022331Cardiac Gating Monitor & Accessory Kit
00816396021556Cardiac Gating Module
00816396021457Cardiac Gating Module
00816396021440Cardiac Gating Monitor & Accessory Kit
00816396021211Cardiac Gating Module
00816396021204Cardiac Gating Module
00816396020405Cardiac Gating Monitor & Accessory Kit
00816396020399Cardiac Gating Monitor & Accessory Kit
00816396020382Cardiac Gating Monitor & Accessory Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.