Model 7600EP 3303-48-15

GUDID 00816396022904

Cardiac Gating Monitor & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

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• Primary Device ID: 00816396022904
• NIH Device Record Key: 27b9c844-c848-4a99-9b36-1f62318d5c86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 7600EP
• Version Model Number: 3303-48-15
• Catalog Number: 3303-48-15
• 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: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound
• Height: 7.49 Inch
• Width: 7.94 Inch
• Depth: 5.18 Inch
• Weight: 3.9 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396022904 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202138

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 7600EP]

• 00816396023222: Cardiac Gating Monitor & Accessory Kit
• 00816396023215: Cardiac Gating Monitor & Accessory Kit
• 00816396023208: Cardiac Gating Module
• 00816396022928: Cardiac Gating Monitor & Accessory Kit
• 00816396022904: Cardiac Gating Monitor & Accessory Kit
• 00816396022898: Cardiac Gating Monitor & Accessory Kit
• 00816396021495: Cardiac Gating Monitor & Accessory Kit
• 00816396023079: Cardiac Gating Module
• 00816396022881: Cardiac Gating Module
• 00816396022874: Cardiac Gating Module
• 00816396022867: Cardiac Gating Module