FDA.reportPublic FDA data

VYGON

Primary DI
30849884005074
Brand
VYGON
Company
Vygon Corporation
Model
AMS-7517CP-1
Catalog number
AMS-7517CP-1
Device description
ULTRASOUND IV START KIT
Published
2020-12-19
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
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
30849884005074PackageGS120In Commercial Distribution
00849884005073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400507430849884005074
00849884005073008498840050738498840050730849884005073

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). 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, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120818216
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
30849884007474VYGONAMS-7170CPAMS-7170CP2026-03-06
30849884007320VYGONAMS-8070CP AMS-8070CP 2026-02-11
30849884007313VYGONVYLFMM1004 VYLFMM1004 2026-01-23
50849884007300VYGONVYLFMM1003VYLFMM10032026-01-22
30849884007122VYGONVYPL5T1003-1 VYPL5T1003-1 2025-11-20
30849884007146VYGONVYPL4S1001LW-1VYPL4S1001LW-12025-11-20
30849884007030VYGONVYML3S1003-1 VYML3S1003-1 2025-09-26
30849884007078VYGONVYPL3S1003-1VYPL3S1003-12025-09-26
30849884007214VYGONAMS-9777CPAMS-9777CP2025-09-26
30849884007047VYGONVYML4D1003-1 VYML4D1003-1 2025-09-25
30849884007085VYGONVYPL4D1003-1 VYPL4D1003-1 2025-09-25
30849884007207VYGONAMS-2087CPAMS-2087CP2025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160393306MEDLINEMEDLINE INDUSTRIES, INC.LRS2026-05-26
50198956425345CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-23
50198956373141CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-19
50198956374711CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-19
50810010894927Aero-MedAERO-MED, LLCLRS2026-03-17
50810010894934Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894977Aero-MedAERO-MED, LLCLRS2026-03-17
00810010894984Aero-MedAERO-MED, LLCLRS2026-03-17
50198956398571CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-16
50198956406597CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-16
50198956375428CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-10
10653160392576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
10653160392637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
10653160392682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-05
20809160514938Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRS2026-03-04
50198956348828CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-03
20809160514754MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-03-03
20809160514761MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.LRS2026-03-03
50198956332063CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-02
50198956348446CARDINAL HEALTHCardinal Health 200, LLCLRS2026-03-02
10653160392583Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-03-02
10653160392323Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
10653160392385Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
10653160392460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-26
50198956323528CARDINAL HEALTHCardinal Health 200, LLCLRS2026-02-23
50198956363616CARDINAL HEALTHCardinal Health 200, LLCLRS2026-02-23
10653160392057Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
10653160392064Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
10653160392231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LRS2026-02-11
00842209137619NAR KitNORTH AMERICAN RESCUE, LLCLRS2026-02-10