FDA.reportPublic FDA data

VYGON

Primary DI
08498840001172
Brand
VYGON
Company
Vygon Corporation
Model
AMS-467C
Catalog number
AMS-467C
Device description
"60"" ULTRA MICROBORE EXTENSION SET WITH MALE/FEMALE LUER LOCKS"
Published
2017-07-05
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
FPASet, administration, intravascular

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021395000MODIFICATION TO 30 EXTENSION SETChurchill Medical Systems, Inc.2002-05-13FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840001173PackageGS1100In Commercial Distribution
08498840001172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000117338498840001173
08498840001172084988400011728498840001172

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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
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
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
08498840012635VYGONVygon CorporationFPA2019-06-17
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