FDA.report

VYGON

Primary DI
33660812042018
Brand
VYGON
Company
VYGON
Model
821.022
Catalog number
821.022
Device description
Vial access cap with Nutrisafe 2 connection
Published
2016-09-13
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

Related Records

Product Codes

CodeName
FPDTUBE, FEEDING

Product Code Classifications

CodeDeviceSpecialtyClass
FPDTube, FeedingGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
33660812042018PackageGS125In Commercial Distribution
53660812042012PackageGS18In Commercial Distribution
03660812042017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3366081204201833660812042018
5366081204201253660812042012
03660812042017036608120420173660812042017

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods

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 DIBrandModelCatalogPublished
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31
33660812114845VYGON1366.067100136606712025-03-31
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53660812145935VYGON1362.107200136210722025-03-31
33660812147089VYGON1366.147100136614712025-03-31
53660812154227VYGON1362.067100136206712025-03-31
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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 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
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