Model 7600 3303-08-15

GUDID 00816396020078

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

Nuclear medicine system synchronizer

• Primary Device ID: 00816396020078
• NIH Device Record Key: 00871028-dcf2-44f1-bdca-c7d9fbb1f580
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 7600
• Version Model Number: 3303-08-15
• Catalog Number: 3303-08-15
• 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: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch
• Height: 7.49 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396020078 [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 7600]

• 00816396022461: Cardiac Gating Module
• 00816396022454: Cardiac Gating Monitor & Accessory Kit
• 00816396022249: Cardiac Gating Monitor & Accessory Kit
• 00816396022232: Cardiac Gating Monitor & Accessory Kit
• 00816396022119: Cardiac Gating Module
• 00816396021983: Cardiac Gating Monitor & Accessory Kit
• 00816396021976: Cardiac Gating Module
• 00816396021952: Cardiac Gating Module
• 00816396021945: Cardiac Gating Module
• 00816396021938: Cardiac Gating Module
• 00816396021518: Cardiac Gating Module
• 00816396021488: Cardiac Gating Module
• 00816396021471: Cardiac Gating Monitor & Accessory Kit
• 00816396021198: Cardiac Gating Module
• 00816396021181: Cardiac Gating Module
• 00816396021174: Cardiac Gating Module
• 00816396021167: Cardiac Gating Module
• 00816396021150: Cardiac Gating Module
• 00816396021143: Cardiac Gating Module
• 00816396021136: Cardiac Gating Module
• 00816396021129: Cardiac Gating Module
• 00816396021112: Cardiac Gating Module
• 00816396021105: Cardiac Gating Module
• 00816396021099: Cardiac Gating Module
• 00816396021082: Cardiac Gating Module
• 00816396021075: Cardiac Gating Module
• 00816396021068: Cardiac Gating Module
• 00816396021051: Cardiac Gating Module
• 00816396021044: Cardiac Gating Module
• 00816396021037: Cardiac Gating Module
• 00816396021020: Cardiac Gating Module
• 00816396021013: Cardiac Gating Module
• 00816396021006: Cardiac Gating Module
• 00816396020993: Cardiac Gating Module
• 00816396020986: Cardiac Gating Module
• 00816396020979: Cardiac Gating Module
• 00816396020962: Cardiac Gating Module
• 00816396020955: Cardiac Gating Module
• 00816396020948: Cardiac Gating Module
• 00816396020375: Cardiac Gating Monitor & Accessory Kit
• 00816396020368: Cardiac Gating Monitor & Accessory Kit
• 00816396020351: Cardiac Gating Monitor & Accessory Kit
• 00816396020344: Cardiac Gating Monitor & Accessory Kit
• 00816396020337: Cardiac Gating Monitor & Accessory Kit
• 00816396020320: Cardiac Gating Monitor & Accessory Kit
• 00816396020313: Cardiac Gating Monitor & Accessory Kit
• 00816396020306: Cardiac Gating Monitor & Accessory Kit
• 00816396020290: Cardiac Gating Monitor & Accessory Kit
• 00816396020283: Cardiac Gating Monitor & Accessory Kit
• 00816396020276: Cardiac Gating Monitor & Accessory Kit