Technegas Plus System 25000

GUDID 09340598000015

CYCLOMEDICA AUSTRALIA PTY LTD

Technetium-labelled carbon aerosol generator

• Primary Device ID: 09340598000015
• NIH Device Record Key: 0a18d21d-730e-46ad-bc3b-470291c7b538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Technegas Plus System
• Version Model Number: None
• Catalog Number: 25000
• Company DUNS: 751444290
• Company Name: CYCLOMEDICA AUSTRALIA PTY LTD
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	09340598000015 [Primary]
GS1	19340598000050 [Package]; Package: Carton [1 Units]; In Commercial Distribution

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: 2023-11-14
• Device Publish Date: 2023-11-06

Devices Manufactured by CYCLOMEDICA AUSTRALIA PTY LTD

• 09340598000015 - Technegas Plus System: 2023-11-14
• 09340598000015 - Technegas Plus System: 2023-11-14
• 09340598000091 - Patient Administration Set: 2023-11-08
• 09340598000046 - Patient Administration Set: 2023-04-19