TEVADAPTOR® Vial Adaptor

Basic Information

• Brand Name: TEVADAPTOR® Vial Adaptor
• Primary DI: 17298119121116
• Version / Model: MG412111
• Catalog Number: MG412111
• Company Name: TEVA PHARMACEUTICAL INDUSTRIES LIMITED
• Labeler DUNS: 600029649
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 326c9055-c07f-4207-8d42-4b5bcbd7f116

Device Description

TEVADAPTOR® 20 mm Vial Adaptor and 13mm converter for use with OnGuardTM contained Medication System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONB	Closed antineoplastic and hazardous drug reconstitution and transfer system	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41222	Medication transfer set	A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27298119121113	GS1		4	In Commercial Distribution
Primary	17298119121116	GS1
Unit of Use	07298119121119	GS1

Premarket Submissions

Submission Number	Supplement Number
K141448	000