FDA.reportPublic FDA data

Vented Vial Adapter Transfer Device

Primary DI
17290108241331
Brand
Vented Vial Adapter Transfer Device
Company
WEST PHARMA. SERVICES IL, . LTD
Model
8073051
Catalog number
8073051
Device description
Vented Vial Adapter 20mm FLL- VF
Published
2022-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K062482000
K213513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062482000VENTED VIAL ADAPTER TRANSFER DEVICEMedimop Medical Projects, Ltd.2006-11-03LHI
K213513000Vented Vial Adapter 20mmWest Pharma. Services IL, Ltd.2022-08-31LHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290108241331PackageGS128In Commercial Distribution
27290108241338PackageGS1336In Commercial Distribution
07290108241334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010824133117290108241331
2729010824133827290108241338
07290108241334072901082413347290108241334

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, filtering/ventedA slender, rigid, sharp or blunt, dual-lumen 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 is designed to puncture the vial septum, aspirate medication and simultaneously allow air into the vial to reduce back-pressure; it has an integral filter intended to prevent the ingress of airborne microbial contaminants. Typically, the proximal end is a Luer connector. The device is sometimes referred to as vent spike. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600267793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290108241518Vial2Bag Advanced 20mm Admixture Device60700312026-03-17
07290108241334Vented Vial Adapter Transfer Device807305180730512022-11-23
07290108240238Vial Adapter 15mm 80750032018-02-08
07290108241013MIXJECT9701132016-05-01
07290108240931Mixject (TM) with spray head90701132016-05-01
07290108240009Vial Adapter80720282016-05-01
07290108241433Vial2Bag Advanced® 13mm Admixture Device607003460700342024-06-23
17290108241430Vial2Bag Advanced® 13mm Admixture Device607003460700342024-06-23
07290108240900ID Adapter50702042016-11-18
07290108240368Vented Vial Adapter Transfer Device80730172016-05-01
07290108240108Swabable Vented Vial Adapter80730092016-05-01
07290108240160Vial Adaptor80703012016-05-01
07290108240276Vial Adaptor80721202016-05-01
07290108240733Vial Adaptor80721162016-05-01
07290108240740Swabable Vented Vial Adapter80730112016-05-01
07290108240917Swabable Vented Vial Adapter80730212016-05-01
07290108240924Vial Adapter80701122016-05-01
07290108241044MIXJECT90701152016-05-01
07290108240771Mix2Vial 20/20mm80740292023-06-15
07290108241099Vial Adapter 20mm with silicon80000162023-06-15

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