Vented Vial Adapter Transfer Device

Basic Information

• Brand Name: Vented Vial Adapter Transfer Device
• Primary DI: 07290108241334
• Version / Model: 8073051
• Catalog Number: 8073051
• 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: 2022-11-23
• Public Version: 3
• Public Version Date: 2023-12-21
• Public Version Status: Update
• Public Device Record Key: 48d94271-59ac-4548-9cdb-bb996a4b0368

Device Description

Vented Vial Adapter 20mm FLL- 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: 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: Yes
• Sterilization Prior Use: No

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
60537	Vial/bottle adaptor, hermetic	A device intended to be fitted to a vial or bottle to enable the airtight removal of its contents (e.g., medication) into a syringe, for subsequent administration to a patient. It is typically a housing with a spike that attaches to or replaces the container lid, plus a Luer connection and sealed expansion chamber (e.g., balloon), allowing for pressure equalization intended to prevent the egress and ingress of materials (e.g., vapours, microbes). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290108241331	GS1	Intermediate Box	28	In Commercial Distribution
Primary	07290108241334	GS1
Package	27290108241338	GS1	Shipping Case	336	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K062482	000
K213513	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius