FDA.reportPublic FDA data

VYGON

Primary DI
30849884000772
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9152CP-1
Catalog number
AMS-9152CP-1
Device description
MAXIMUM BARRIER INSERTION TRAY
Published
2020-02-10
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
30849884000772PackageGS110In Commercial Distribution
00849884000771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400077230849884000772
00849884000771008498840007718498840007710849884000771

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. 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
10198956477940CARDINAL HEALTHCardinal Health 200, LLCOWL2026-05-25
20809160517113MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OWL2026-03-23
30849884007474VYGONVygon CorporationOWL2026-03-06
30849884007320VYGONVygon CorporationOWL2026-02-11
50198956291667CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
50198956188127CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
50198956266665CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
50198956263558CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
50198956257113CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
50198956184457CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
50198956165432CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
20809160486389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OWL2025-07-22
50197106694808CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10661392007663LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392007830LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
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10661392025759LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392025827LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027548LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027555LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027678LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392028309LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037899LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037981LSL HEALTHCARELSL Industries, LLCOWL2025-05-16