Cardius 1

GUDID 00850816007096

DIGIRAD CORPORATION

SPECT system, annular detector array

• Primary Device ID: 00850816007096
• NIH Device Record Key: a20a3f07-8c07-4cea-8823-a55415fee510
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardius 1
• Version Model Number: Mobile
• Company DUNS: 148548738
• Company Name: DIGIRAD CORPORATION
• 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: 8587261600
• Email: callcenter@digirad.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850816007096 [Primary]

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

Devices Manufactured by DIGIRAD CORPORATION

• 00850816007195 - Breast Imaging Accessory: 2019-03-11
• 00850816007027 - LEHR Collimator: 2018-03-29
• 00850816007034 - Cardius 2: 2018-03-29
• 00850816007041 - Cardius 2: 2018-03-29
• 00850816007058 - Cardius 2: 2018-03-29
• 00850816007065 - Cardius 2: 2018-03-29
• 00850816007072 - Cardius 3: 2018-03-29
• 00850816007089 - Cardius 3: 2018-03-29