R2*/T2* Phantom -

GUDID 09355529000088

The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).

RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

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• Primary Device ID: 09355529000088
• NIH Device Record Key: b8352382-be4b-4760-9a08-9dfb48fdc8df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R2*/T2* Phantom
• Version Model Number: v1.0
• Catalog Number: -
• Company DUNS: 740449913
• Company Name: RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com
• Phone: +61892865300
• Email: quality@resonancehealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 13 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09355529000088 [Primary]

FDA Product Code

• IXG: Phantom, Anthropomorphic, Radiographic

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: 2024-04-25
• Device Publish Date: 2024-04-17

Devices Manufactured by RESONANCE HEALTH ANALYSIS SERVICES PTY LTD

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