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| 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 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| mics@lantheus.com | |
| Phone | 800-299-3431 |
| 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 |
Trademark Results [VIALMIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIALMIX 78100860 2628446 Live/Registered |
LANTHEUS MEDICAL IMAGING, INC. 2002-01-04 |
 VIALMIX 75733921 not registered Dead/Abandoned |
DuPont Pharmaceuticals Company 1999-06-22 |
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