VIAL ADAPTER WITH FILTER

Basic Information

• Brand Name: VIAL ADAPTER WITH FILTER
• Primary DI: 46975124931368
• Version / Model: VA-DF20L05
• 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: a605f911-946b-436e-8256-ec2d60ccd974

Device Description

The Vial adapter with filter consists of an interface, a housing, a membrane ring, a filter membrane and a puncture section; the interface, the housing and the puncture section are made of polycarbonate (PC), the membrane ring is made of polyethylene (PE) and the filter membrane is made of polyamide (PA) or acrylic (AA). The vial adapter with filter 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
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	26975124931364	GS1	secondary box	150	In Commercial Distribution
Primary	46975124931368	GS1
Package	06975124931360	GS1	carton	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K233284	000