FDA.reportPublic FDA data

VIAL ADAPTER WITH FILTER

Primary DI
46975124931368
Brand
VIAL ADAPTER WITH FILTER
Company
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Model
VA-DF20L05
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.
Published
2026-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233284000Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-01LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975124931360PackageGS14In Commercial Distribution
26975124931364PackageGS1150In Commercial Distribution
46975124931368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975124931360069751249313606975124931360
2697512493136426975124931364
4697512493136846975124931368

GMDN Terms#

Term, Definition table
TermDefinition
Vial/bottle adaptor, non-hermeticA 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.

Regulatory Flags#

DUNS number
601849929
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
46975124930965 Filter Needle for Single UseFN-B1838RW2026-04-11
46975124931252VENTED VIAL ADAPTERVA-AF13S2026-04-11
46975124930071N/AVA-1F132023-10-31

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