FDA.reportPublic FDA data

VYGON

Primary DI
03660812009232
Brand
VYGON
Company
VYGON
Model
873.04
Catalog number
00087304
Device description
Ramp of stopcocks Luer-lock with extension tube L.50cm - 4 one-way stopcocks
Published
2021-06-09
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812009233PackageGS125In Commercial Distribution
53660812009237PackageGS16In Commercial Distribution
03660812009232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081200923333660812009233
5366081200923753660812009237
03660812009232036608120092323660812009232

GMDN Terms#

Term, Definition table
TermDefinition
Infusion line manifoldA sterile, noninvasive device intended to provide multiple connections to an infusion fluid path. It consists of a straight-through infusion path with appropriate connectors at each end having multiple stopcock-controlled alternative connections to allow the injection/infusion of multiple different fluids/drugs. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
392994778
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03660812123075VYGON5804.04005804042021-06-09
03660812123082VYGON5804.08005804082021-06-09
03660812141536VYGON115.11000115112023-08-24
03660812141567VYGON115.0900001150902023-07-03
03660812094535VYGON368.47000368472025-03-31
03660812106627VYGON1366.167100136616712025-03-31
03660812114844VYGON1366.067100136606712025-03-31
03660812118910VYGON1366.107100136610712025-03-31
03660812118927VYGON1366.107200136610722025-03-31
03660812118941VYGON1366.087100136608712025-03-31
03660812118958VYGON1366.087200136608722025-03-31
03660812126397VYGON1366.127100136612712025-03-31
03660812126403VYGON1366.127200136612722025-03-31
03660812145329VYGON1362.127200136212722025-03-31
03660812145923VYGON1362.107100136210712025-03-31
03660812145930VYGON1362.107200136210722025-03-31
03660812147088VYGON1366.147100136614712025-03-31
03660812154222VYGON1362.067100136206712025-03-31
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10193489058970NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
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