Vial Adapter

Basic Information

• Brand Name: Vial Adapter
• Primary DI: 07290108240702
• Version / Model: 8070151
• Company Name: WEST PHARMA. SERVICES IL, . LTD
• Labeler DUNS: 600267793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-01
• Public Version: 7
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: 10754b7e-1f22-4011-894b-3e197c466c7f

Device Description

Vial Adapter 13mm FLL SIL - VF

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
60539	Vial/bottle adaptor, non-hermetic	A device intended to be fitted to a vial or bottle to enable the removal of its contents, (e.g., medication, nutritional solution for enteral feeding) into a syringe, for subsequent administration to a patient. It is typically a housing with a barbed connection or spike that attaches to or replaces the container lid, and a small bore connection (typically ENFit or a Luer); it does not allow for pressure equalization/airtight transfer of contents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27290108240706	GS1		8	In Commercial Distribution
Package	17290108240709	GS1		150	In Commercial Distribution
Primary	07290108240702	GS1

Premarket Submissions

Submission Number	Supplement Number
K001293	000