ViaMed

Basic Information

• Brand Name: ViaMed
• Primary DI: 00811382013119
• Version / Model: 17001-R
• Company Name: RECE INTERNATIONAL CORPORATION
• Labeler DUNS: 787828537
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2019-05-20
• Public Version: 2
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 5652678e-cf2e-48c3-ac2d-3e6f06ae0ff9

Device Description

Sharp Container 1 Galon

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMK	Container, Sharps	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14426	Contaminated waste container	A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials (e.g., waste products containing or having been in contact with human blood, sputum, urine and/or faeces). It is not intended to exclusively contain sharps or for in vitro diagnostic purposes. It is typically used with a disposable liner and has a self-closing lid. It is typically identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811382013119	GS1
Unit of Use	00811382010170	GS1

Premarket Submissions

Submission Number	Supplement Number
K082042	000