RPM Respiratory Gating System

GUDID 00899475002479

VARIAN MEDICAL SYSTEMS, INC.

Real-time position management respiratory gating system, optical

• Primary Device ID: 00899475002479
• NIH Device Record Key: 74713607-3425-4f3c-8544-c3ce5a9e1492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RPM Respiratory Gating System
• Version Model Number: 1.8
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899475002479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102024

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2022-04-29
• Device Publish Date: 2022-04-21

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

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• 00810563023015 - Ovoid mini Ø16 mm Right: 2025-05-30
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• 00858086006818 - IDENTIFY: 2025-03-05
• 30816389027290 - Fixation buttons, pack of 10, sterile: 2025-02-21
• 00855141006349 - Eclipse Treatment Planning System: 2024-12-30