CardioGraphe

GUDID 07290016484007

The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.

ARINETA LTD

Full-body CT system

• Primary Device ID: 07290016484007
• NIH Device Record Key: e1c0e3a7-157e-48ff-8efa-2b49137790e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioGraphe
• Version Model Number: Spotlight
• Company DUNS: 514896484
• Company Name: ARINETA 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

Customer Support Contacts

• Phone: +97246374000
• Email: udi.dafni@arineta.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016484007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161066

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2019-02-01
• Device Publish Date: 2019-01-01

Devices Manufactured by ARINETA LTD

• 07290016484014 - SpotLight: 2023-09-15 SpotLight is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
• 07290016484021 - SpotLight Duo: 2023-09-15 SpotLight Duo is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
• 07290016484007 - CardioGraphe: 2019-02-01The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.
• 07290016484007 - CardioGraphe: 2019-02-01 The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.