Model 7800 3300-01-15

GUDID 00816396021235

Cardiac Gating Module

IVY BIOMEDICAL SYSTEMS, INC.

X-ray system synchronizer

• Primary Device ID: 00816396021235
• NIH Device Record Key: bfa4f100-9a7d-452c-a1c9-b88e31790335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 7800
• Version Model Number: 3300-01-15
• Catalog Number: 3300-01-15
• 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

Device Dimensions

• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch
• Height: 8.72 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396021235 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

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