VENTED VIAL ADAPTER

Basic Information

• Brand Name: VENTED VIAL ADAPTER
• Primary DI: 46975124931252
• Version / Model: VA-AF13S
• Company Name: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
• Labeler DUNS: 601849929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-11
• Public Version: 1
• Public Version Date: 2026-04-20
• Public Version Status: New
• Public Device Record Key: b5020510-ddab-4047-81ef-32aea71f19e5

Device Description

The Vented vial adapter consists of an interface, a lid, a housing, a filter membrane and a puncture section; the interface, the lid, the housing and the puncture section are made of polycarbonate (PC) and the filter membrane is made of polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE). The vial adapter is indicated for the transfer and mixing of drugs contained in vials.

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: 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	26975124931258	GS1	secondary box	150	In Commercial Distribution
Primary	46975124931252	GS1
Package	06975124931254	GS1	carton	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K233287	000