FDA.reportPublic FDA data

VYGON

Primary DI
08498840005088
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9294CS
Catalog number
AMS-9294CS
Device description
UMBILICAL CATHETER INSERTION TRAY WITH PREVANTICS
Published
2016-09-15
Public version status
Update
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
38498840005089PackageGS110In Commercial Distribution
08498840005088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000508938498840005089
08498840005088084988400050888498840005088

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of 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/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

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
00849884007619VYGONAMS-9869CSAMS-9869CS2026-08-31
00849884007718VYGONMS022MS0222026-10-19
00849884007770VYGONPIP100000TPIP100000T2026-10-09
08498840001691VYGONAMS-6180CPAMS-6180CP2016-08-09
08498840001707VYGONAMS-6186CPAMS-6186CP2016-08-09
08498840002148VYGONAMS-7192CS-2AMS-7192CS-22016-09-15
08498840002735VYGONAMS-8133AMS-81332016-09-07
08498840002889VYGONAMS-8180-3CPAMS-8180-3CP2016-09-07
08498840002902VYGONAMS-8181CPAMS-8181CP2016-09-07
08498840002940VYGONAMS-8198-1AMS-8198-12016-09-15
08498840002957VYGONAMS-8198CSAMS-8198CS2016-09-15
08498840002964VYGONAMS-8199AMS-81992016-09-15
08498840003213VYGONAMS-8280CP-4AMS-8280CP-42016-09-15
08498840003688VYGONAMS-8423CPAMS-8423CP2016-09-07
08498840004005VYGONAMS-8485CP-1AMS-8485CP-12016-09-15
08498840004333VYGONAMS-8712CP-1AMS-8712CP-12016-09-02
08498840004784VYGONAMS-9093CPAMS-9093CP2016-09-02
08498840004814VYGONAMS-9152CPAMS-9152CP2016-09-02
08498840004951VYGONAMS-923CPAMS-923CP2016-09-02
08498840005071VYGONAMS-9294AMS-92942016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007718VYGONVygon CorporationOWL2026-10-19
10198956586963CARDINAL HEALTHCardinal Health 200, LLCOWL2026-10-12
00849884007770VYGONVygon CorporationOWL2026-10-09
10198956577770CARDINAL HEALTHCardinal Health 200, LLCOWL2026-10-06
10198956561694CARDINAL HEALTHCardinal Health 200, LLCOWL2026-09-25
00849884007619VYGONVygon CorporationOWL2026-08-31
00849884007497VYGONVygon CorporationOWL2026-04-24
00849884007480VYGONVygon CorporationOWL2026-04-09
00849884007473VYGONVygon CorporationOWL2026-03-06
00849884007329VYGONVygon CorporationOWL2026-02-11
00849884007299VYGONVygon CorporationOWL2025-11-10
00849884007282VYGONVygon CorporationOWL2025-10-10
10197106694800CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
00849884006933VYGONVygon CorporationOWL2025-05-09
10198956048850CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-17
10198956033917CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-09
10198956024274CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-31
00849884006902VYGONVygon CorporationOWL2025-03-31
10198956012912CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-25
10197106982013CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-05
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