FDA.reportPublic FDA data

VYGON

Primary DI
53660812115501
Brand
VYGON
Company
VYGON
Model
80246.10L
Catalog number
80246.10L
Device description
Needle with double wings - PICC introducer 19G - 1.0mm - L.27mm
Published
2020-01-29
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812115507PackageGS1100In Commercial Distribution
53660812115501PackageGS124In Commercial Distribution
03660812115506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081211550733660812115507
5366081211550153660812115501
03660812115506036608121155063660812115506

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
392994778
Device count
1
DM exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840010730Churchill Medical SystemsVygon CorporationFPA2020-05-21
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840010266Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010372Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840010389Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
08498840011638VYGONVygon CorporationFPA2020-03-12
08498840010518Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840010525Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840010532Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840010549Churchill Medical SystemsVygon CorporationFPA2019-05-20
08498840012239VYGONVygon CorporationFPA2019-04-17
08498840000014VYGONVygon CorporationFPA2017-07-28
08498840009833VYGONVygon CorporationFPA2017-07-28
08498840010846VYGONVygon CorporationFPA2017-07-28
08498840010853VYGONVygon CorporationFPA2017-07-28
08498840010860VYGONVygon CorporationFPA2017-07-28
08498840010877VYGONVygon CorporationFPA2017-07-28
08498840010884VYGONVygon CorporationFPA2017-07-28
08498840010891VYGONVygon CorporationFPA2017-07-28
08498840010907VYGONVygon CorporationFPA2017-07-28