FDA.reportPublic FDA data

VYGON

Primary DI
08498840006511
Brand
VYGON
Company
Vygon Corporation
Model
CMS-8000
Catalog number
CMS-8000
Device description
NEEDLELESS CONNECTOR BIONECTOR
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070705000MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039Vygon Corp.2007-11-30FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840006512PackageGS1100In Commercial Distribution
08498840006511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000651238498840006512
08498840006511084988400065118498840006511

GMDN Terms#

Term, Definition table
TermDefinition
Neutral-pressure intravenous line needleless valve-connectorA small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Regulatory Flags#

DUNS number
120818216
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849884007589VYGONVYML4S3001NVYML4S3001N2026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902218404ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
10801902224436ARROWTELEFLEX INCORPORATEDFOZ2026-08-01
00382903935314NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFOZ2026-07-30
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10801902129700ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
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10801902167894ARROWTELEFLEX INCORPORATEDFOZ2026-07-28
10801902226379ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226386ARROWTELEFLEX INCORPORATEDFOZ2026-07-14
10801902226140ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226157ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
10801902226164ARROWTELEFLEX INCORPORATEDFOZ2026-06-12
00850073657003Ruby Intravascular CatheterVenocare, Inc.FOZ2026-04-08
10801902219449ARROWTELEFLEX INCORPORATEDFOZ2026-03-06
10192253040241ArgyleCardinal Health 200, LLCFOZ2025-01-08
10192253040258ArgyleCardinal Health 200, LLCFOZ2025-01-08