Vented Vial Adapter Transfer Device

Basic Information

• Brand Name: Vented Vial Adapter Transfer Device
• Primary DI: 07290108240368
• Version / Model: 8073017
• Company Name: WEST PHARMA. SERVICES IL, . LTD
• Labeler DUNS: 600267793
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-01
• Public Version: 7
• Public Version Date: 2023-12-01
• Public Version Status: Update
• Public Device Record Key: 53f7cdea-84df-48a2-820b-b717ca119c4c
• Distribution End Date: 2019-05-01

Device Description

VA 20mm Vented FLL w/o filter- SF

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHI	Set, I.V. Fluid Transfer	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60822	Medication transfer needle, filtering/vented	A slender, rigid, sharp or blunt, dual-lumen tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290108240362	GS1		4	Not in Commercial Distribution	2019-05-01
Package	17290108240365	GS1		150	Not in Commercial Distribution	2019-05-01
Primary	07290108240368	GS1

Premarket Submissions

Submission Number	Supplement Number
K062482	000