Model 7800 3304-39-15

GUDID 00816396023109

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

X-ray system synchronizer

Primary Device ID	00816396023109
NIH Device Record Key	136ef203-cf89-438a-b8a2-ebf5f28bb91a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Model 7800
Version Model Number	3304-39-15
Catalog Number	3304-39-15
Company DUNS	109132019
Company Name	IVY BIOMEDICAL SYSTEMS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com
Phone	203-481-4183
Email	sales@ivybiomedical.com

Device Dimensions

Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound
Height	8.72 Inch
Width	9.25 Inch
Depth	6.1 Inch
Weight	5.6 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396023109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K110987

FDA Product Code

DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-16
Device Publish Date	2023-06-08

On-Brand Devices [Model 7800]

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