FDA.reportPublic FDA data

VENTED VIAL ADAPTER

Primary DI
46975124931252
Brand
VENTED VIAL ADAPTER
Company
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Model
VA-AF13S
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.
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
K233287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233287000Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-07-26LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975124931254PackageGS14In Commercial Distribution
26975124931258PackageGS1150In Commercial Distribution
46975124931252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975124931254069751249312546975124931254
2697512493125826975124931258
4697512493125246975124931252

GMDN Terms#

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

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
46975124931368VIAL ADAPTER WITH FILTERVA-DF20L052026-04-11
46975124930071N/AVA-1F132023-10-31

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Primary DI, Brand, Company table
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