CTM-300 2882-03-01

GUDID 00816396021419

Cardiac Gating Module

IVY BIOMEDICAL SYSTEMS, INC.

Nuclear medicine system synchronizer Nuclear medicine system synchronizer Nuclear medicine system synchronizer

• Primary Device ID: 00816396021419
• NIH Device Record Key: b28ac2ff-f968-4f2b-8033-2e53950021e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CTM-300
• Version Model Number: 2882-03-01
• Catalog Number: 2882-03-01
• 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: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch
• Height: 2.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396021419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083854

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: 2016-11-07

On-Brand Devices [CTM-300]

• 00816396021419: Cardiac Gating Module
• 00816396021402: Cardiac Gating Module
• 00816396020771: Cardiac Gating Module & Accessory Kit
• 00816396020764: Cardiac Gating Module & Accessory Kit
• 00816396020757: Cardiac Gating Module & Accessory Kit
• 00816396020740: Cardiac Gating Module & Accessory Kit