Model 7700 3607-01-15

GUDID 00816396020399

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

X-ray system synchronizer

• Primary Device ID: 00816396020399
• NIH Device Record Key: 21a3f74a-78f6-416a-b2ba-e046b0633a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 7700
• Version Model Number: 3607-01-15
• Catalog Number: 3607-01-15
• 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: true
• 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: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch
• Height: 7 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396020399 [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: 2016-10-14

On-Brand Devices [Model 7700]

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