CTM-400 3310-02-15

GUDID 00816396020801

Cardiac Gating Module & Accessory Kit

IVY BIOMEDICAL SYSTEMS, INC.

X-ray system synchronizer

• Primary Device ID: 00816396020801
• NIH Device Record Key: 15b62ec6-cb0e-48b9-9b71-b131f3c9ed8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CTM-400
• Version Model Number: 3310-02-15
• Catalog Number: 3310-02-15
• Company DUNS: 109132019
• Company Name: IVY BIOMEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch
• Height: 2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816396020801 [Primary]

FDA Product Code

• IXO: Synchronizer, Ecg/Respirator, Radiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-10

On-Brand Devices [CTM-400]

• 00816396022171: Cardiac Gating Module
• 00816396020801: Cardiac Gating Module & Accessory Kit
• 00816396020795: Cardiac Gating Module & Accessory Kit
• 00816396020788: Cardiac Gating Module & Accessory Kit