Cardius 2

GUDID 00850816007065

DIGIRAD CORPORATION

SPECT system, annular detector array

• Primary Device ID: 00850816007065
• NIH Device Record Key: 2fcc293d-0b19-4781-b448-01cd50cc832b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardius 2
• Version Model Number: Mobile XPOL
• 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	00850816007065 [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

On-Brand Devices [Cardius 2]

• 00850816007065: Mobile XPOL
• 00850816007058: XPOD International
• 00850816007041: Mobile XPOD
• 00850816007034: XPOD