FDA.reportPublic FDA data

Vial2Bag Advanced® 13mm Admixture Device

Primary DI
17290108241430
Brand
Vial2Bag Advanced® 13mm Admixture Device
Company
WEST PHARMA. SERVICES IL, . LTD
Model
6070034
Catalog number
6070034
Device description
Vial2Bag Advanced® 13mm Admixture Device
Published
2024-06-23
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290108241430PackageGS150In Commercial Distribution
27290108241437PackageGS13In Commercial Distribution
07290108241433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010824143017290108241430
2729010824143727290108241437
07290108241433072901082414337290108241433

GMDN Terms#

Term, Definition table
TermDefinition
Fluid transfer set, general-purposeA collection of devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it is not dedicated to a particular type of fluid or clinical procedure. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage 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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
07290108241105VA 13mm with Silicon80703142023-06-15

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