VIALMIX®RFID VMIX2

GUDID 00866709000402

Class I medical device, Amalgamator, Dental, AC-powered. Used to activate vials of DEFINITY® RT, and DEFINITY®, Vial for (Perflutren Lipid Microsphere) Injectable Suspension prior to use.

LANTHEUS MEDICAL IMAGING, INC.

Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer Dental amalgam mixer

• Primary Device ID: 00866709000402
• NIH Device Record Key: 907c477b-c423-4ed2-8333-79f410eea175
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIALMIX®RFID
• Version Model Number: VMIX2
• Catalog Number: VMIX2
• Company DUNS: 176786812
• Company Name: LANTHEUS MEDICAL IMAGING, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com
• Phone: 800-299-3431
• Email: mics@lantheus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866709000402 [Primary]

FDA Product Code

• EFD: Amalgamator, Dental, Ac-Powered

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: 2020-09-23
• Device Publish Date: 2020-09-15