Filter Needle for Single Use

Basic Information

• Brand Name: Filter Needle for Single Use
• Primary DI: 46975124930965
• Version / Model: FN-B1838RW
• 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: e1ee5fcf-5c76-404f-bef3-470a7864ec59

Device Description

The Filter Needle for Single Use consists of cap, needle cannula,needle hub, sheath and filter. This product is intended for the aspiration, filtration and preparation of medical fluid, not including injection.

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
FPB	Filter, Infusion Line	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16266	Medication transfer needle, filtering	A slender, rigid, sharp or blunt 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 includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26975124930961	GS1	secondary box	200	In Commercial Distribution
Primary	46975124930965	GS1
Package	06975124930967	GS1	carton	8	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K233277	000