FDA.reportPublic FDA data

VYGON

Primary DI
30849884003100
Brand
VYGON
Company
Vygon Corporation
Model
AMS-8126CP-2
Catalog number
AMS-8126CP-2
Device description
VAD ACCESS KIT
Published
2020-12-09
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
OWLPeripheral catheter insertion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884003100PackageGS120In Commercial Distribution
00849884003109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400310030849884003100
00849884003109008498840031098498840031090849884003109

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
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
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10198956266667CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
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10198956184459CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
10198956165434CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
10197106694800CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10198956067981CARDINAL HEALTHCardinal Health 200, LLCOWL2025-05-05
10198956048850CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-17
10198956033917CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-09
10198956024274CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-31
10198956012912CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-25
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10197106892749CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-21
10197106953310CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-18
10197106773017CARDINAL HEALTHCardinal Health 200, LLCOWL2024-11-13
10197106650776CARDINAL HEALTHCardinal Health 200, LLCOWL2024-06-10
10197106538784CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-16
10197106611067CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-11
10197106544327CARDINAL HEALTHCardinal Health 200, LLCOWL2024-01-22
10197106499498CARDINAL HEALTHCardinal Health 200, LLCOWL2023-12-06
10197106488959CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-28
10197106427477CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-27
10197106472781CARDINAL HEALTHCardinal Health 200, LLCOWL2023-10-31
10197106442197CARDINAL HEALTHCardinal Health 200, LLCOWL2023-09-19