FDA.reportPublic FDA data

Vial2Bag Advanced 20mm

Primary DI
10850022888011
Brand
Vial2Bag Advanced 20mm
Company
West Pharmaceutical Services Az, Inc.
Model
6070030
Device description
Vial2Bag Advanced 20mm - Admixture Device
Published
2020-12-23
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850022888018PackageGS150In Commercial Distribution
30850022888015PackageGS1150In Commercial Distribution
10850022888011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085002288801820850022888018
3085002288801530850022888015
1085002288801110850022888011

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
063293484
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850022888018Vial2Bag Advanced 20mm60700302020-12-23

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