SDX System SDX0365V1.0

GUDID 03615070000903

Real-time position management respiratory gating system, spirometry

Primary Device ID	03615070000903
NIH Device Record Key	d463ea80-dd7b-4a7d-9720-09292f33444d
Commercial Distribution Status	In Commercial Distribution
Brand Name	SDX System
Version Model Number	V1.0
Catalog Number	SDX0365V1.0
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

Device Issuing Agency	Device ID
GS1	03615070000903 [Previous]
GS1	03760290230125 [Primary]

LHN	System, Radiation Therapy, Charged-Particle, Medical

Steralize Prior To Use	false
Device Is Sterile	false