SDX System SDX0350V3.0

GUDID 03615070000507

SDX Module

DYN'R

Real-time position management respiratory gating system, spirometry

• Primary Device ID: 03615070000507
• NIH Device Record Key: 4b545029-5cd0-4337-b8a1-3fda7b4fc2ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SDX System
• Version Model Number: 3.0
• Catalog Number: SDX0350V3.0
• Company DUNS: 380807099
• Company Name: DYN'R
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com
• Phone: +33442210734
• Email: dynr@dynr.com
• Phone: +0133442210734
• Email: dynr@dynr.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615070000507 [Previous]
GS1	03760290230019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121845

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

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: 2025-12-11
• Device Publish Date: 2018-10-30