FDA.reportPublic FDA data

VYGON

Primary DI
30849884006552
Brand
VYGON
Company
Vygon Corporation
Model
MSY-2234-1
Catalog number
MSY-2234-1
Device description
10" WINGED INFUSION SET WITH 22 GA. X 0.75" HUBER NEEDLE AND NEEDLELESS Y-SITE
Published
2024-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873957000NON-CORING HUBER TYPE NEEDLESAdvantage Medical Systems, Inc.1987-10-23FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884006552PackageGS11In Commercial Distribution
00849884006551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400655230849884006552
00849884006551008498840065518498840065510849884006551

GMDN Terms#

Term, Definition table
TermDefinition
Vascular port administration setA collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120818216
Device count
1
DM exempt
false
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
00849884007435VYGON2015SPI2015SPI2026-05-22
00849884007442VYGON2015SPIMST2015SPIMST2026-05-22
00849884007459VYGON3015SPI3015SPI2026-05-22
00849884007466VYGON3015SPIMST3015SPIMST2026-05-22
00849884007510VYGONVYML4S3001A-1VYML4S3001A-12026-05-22
00849884007527VYGONVYML5D3003AVYML5D3003A2026-05-22
00849884007541VYGONVIS-1045VIS-10452026-05-22
00849884007558VYGONVIS-1055VIS-10552026-05-22
00849884007350VYGON3017PI3017PI2026-05-01
00849884007374VYGON4018PI4018PI2026-05-01
00849884007398VYGONPIP200000PIP2000002026-05-01
00849884007497VYGONAMS-599AMS-5992026-04-24
00849884007480VYGONVY-MAXPROVY-MAXPRO2026-04-09
00849884007336VYGON2016PI2016PI2026-03-31
00849884007343VYGON2016SPI2016SPI2026-03-31
00849884007367VYGON3017SPI3017SPI2026-03-31
00849884007381VYGON4018SPI4018SPI2026-03-31
00849884007473VYGONAMS-7170CPAMS-7170CP2026-03-06
30849884007474VYGONAMS-7170CPAMS-7170CP2026-03-06
00849884007404VYGONPIP200100PIP2001002026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08800145524667JBP Nanocannula 23Gx40mmFeeltech Co.,Ltd.FMI2026-04-16
08800052609242Sure Fine Pen Needle 32G x 4mmSHINA MED CORPORATIONFMI2026-03-25
08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03