AccessGUDID - DEVICE: VIALMIX®RFID (00866709000402)

GUDID

Device Identifier (DI) Information

Brand Name: VIALMIX®RFID
Version or Model: VMIX2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VMIX2
Company Name: LANTHEUS MEDICAL IMAGING, INC.

Primary DI Number: 00866709000402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176786812 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10082	Dental amalgam mixer	A mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFD	Amalgamator, Dental, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 907c477b-c423-4ed2-8333-79f410eea175
Public Version Date: September 23, 2020
Public Version Number: 1
DI Record Publish Date: September 15, 2020