FDA.reportPublic FDA data

VYGON

Primary DI
33660812008793
Brand
VYGON
Company
VYGON
Model
821.21
Catalog number
821.21
Device description
No-needle vial access cap with Bionector
Published
2016-09-12
Public version status
Update
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
FPDTUBE, FEEDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812008793PackageGS150In Commercial Distribution
53660812008797PackageGS112In Commercial Distribution
03660812008792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081200879333660812008793
5366081200879753660812008797
03660812008792036608120087923660812008792

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 syringe connector that attaches to the container or replaces its lid; it does not allow for pressure equalization/airtight transfer of contents. 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
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31
33660812114845VYGON1366.067100136606712025-03-31
53660812118915VYGON1366.107100136610712025-03-31
53660812118922VYGON1366.107200136610722025-03-31
53660812118946VYGON1366.087100136608712025-03-31
33660812118959VYGON1366.087200136608722025-03-31
53660812126392VYGON1366.127100136612712025-03-31
33660812126404VYGON1366.127200136612722025-03-31
53660812145324VYGON1362.127200136212722025-03-31
33660812145924VYGON1362.107100136210712025-03-31
53660812145935VYGON1362.107200136210722025-03-31
33660812147089VYGON1366.147100136614712025-03-31
53660812154227VYGON1362.067100136206712025-03-31
53660812145317VYGON1362.127100136212712025-03-20
53660812166541VYGON363.1270003631272025-03-20
33660812064881VYGON5249.7210052497212025-03-15
33660812073388VYGON5557.4500055574502025-03-15
33660812073395VYGON5557.5500055575502025-03-15
53660812073450VYGON81363.062F081363062F2025-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08015262035662NUTRIFITPENTAFERTE ITALIA SRLFPD2025-07-03
53660812094530VYGONVYGONFPD2025-03-31
33660812106628VYGONVYGONFPD2025-03-31
33660812114845VYGONVYGONFPD2025-03-31
53660812118915VYGONVYGONFPD2025-03-31
53660812118922VYGONVYGONFPD2025-03-31
53660812118946VYGONVYGONFPD2025-03-31
33660812118959VYGONVYGONFPD2025-03-31
53660812126392VYGONVYGONFPD2025-03-31
33660812126404VYGONVYGONFPD2025-03-31
53660812145324VYGONVYGONFPD2025-03-31
33660812145924VYGONVYGONFPD2025-03-31
53660812145935VYGONVYGONFPD2025-03-31
33660812147089VYGONVYGONFPD2025-03-31
53660812154227VYGONVYGONFPD2025-03-31
53660812145317VYGONVYGONFPD2025-03-20
53660812166541VYGONVYGONFPD2025-03-20
33660812064881VYGONVYGONFPD2025-03-15
33660812073388VYGONVYGONFPD2025-03-15
53660812073450VYGONVYGONFPD2025-03-15
33660812085473VYGONVYGONFPD2025-03-15
33660812102941VYGONVYGONFPD2025-03-15
53660812109036VYGONVYGONFPD2025-03-15
33660812109063VYGONVYGONFPD2025-03-15
33660812132290VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
33660812132306VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
53660812133079VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
53660812134229VYGONVYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KGFPD2025-03-15
53660812149292VYGONVYGONFPD2025-02-17
53660812094370VYGONVYGONFPD2025-02-15