FDA.reportPublic FDA data

VYGON

Primary DI
00849884007176
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9034CS
Catalog number
AMS-9034CS
Device description
ULTRASOUND IV START KIT
Published
2025-08-14
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
LRSI.V. start kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRSI.V. Start KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884007177PackageGS120In Commercial Distribution
00849884007176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400717730849884007177
00849884007176008498840071768498840071760849884007176

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Regulatory Flags#

DUNS number
120818216
Device count
1
Kit
true
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
10198956279391CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-08
10198956481039CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-08
10198956430235CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956431591CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
10198956480223CARDINAL HEALTHCardinal Health 200, LLCLRS2026-06-01
M689801101006080-110-10 Saline Lock Kit Case of 10Safeguard US Operating, LLCLRS2026-05-29
M68980110150SALINE LOCK KITSafeguard US Operating, LLCLRS2026-05-29
10653160393634MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393665MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393689MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
10653160393719MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-27
M68980100150INTRAVENOUS INFUSION STARTER SETSafeguard US Operating, LLCLRS2026-05-04
M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 20Safeguard US Operating, LLCLRS2026-05-04
09555240405210IV Start KitITL ASIA PACIFIC SDN. BHD.LRS2023-06-28
10193489112672MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-25
10193489111880MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-10-01
10193489111811MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-24
10193489111781MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-17
10193489111668MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-03
10193489111675MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-09-03
10193489111606MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-30
10193489111217OTHERMEDLINE INDUSTRIES, INC.LRS2021-08-27
10193489111545MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-20
10193489111552MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-20
10193489111385MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489111422MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489111446MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-08-13
10193489110876MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-13
10193489111057MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-13
10193489110883MEDLINEMEDLINE INDUSTRIES, INC.LRS2021-07-05