FDA.reportPublic FDA data

VYGON

Primary DI
53660812141531
Brand
VYGON
Company
VYGON
Model
115.11
Catalog number
00011511
Device description
Arterial leadercath - 4Fr - L.10cm - Ø1.2mm - PE
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, intravascular, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
33660812141537PackageGS120In Commercial Distribution
53660812141531PackageGS19In Commercial Distribution
03660812141536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3366081214153733660812141537
5366081214153153660812141531
03660812141536036608121415363660812141536

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral artery cannulaA short, thin tube intended for short-term (<= 30 days) percutaneous access to a peripheral artery for invasive blood pressure monitoring and arterial blood sampling; it may in addition be intended for peripheral IV and/or subcutaneous administration of fluid/medication. Also referred to as a peripheral arterial catheter, it is used with an external blood pressure transducer (not included) to enable pressures to be measured; it does not include electronic sensors and is not intended for thermal dilution techniques. It may include devices dedicated to introduction/function (e.g., introducer needle, guidewire, adaptor). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
392994778
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
03660812123075VYGON5804.04005804042021-06-09
03660812123082VYGON5804.08005804082021-06-09
03660812141536VYGON115.11000115112023-08-24
03660812141567VYGON115.0900001150902023-07-03
03660812094535VYGON368.47000368472025-03-31
03660812106627VYGON1366.167100136616712025-03-31
03660812114844VYGON1366.067100136606712025-03-31
03660812118910VYGON1366.107100136610712025-03-31
03660812118927VYGON1366.107200136610722025-03-31
03660812118941VYGON1366.087100136608712025-03-31
03660812118958VYGON1366.087200136608722025-03-31
03660812126397VYGON1366.127100136612712025-03-31
03660812126403VYGON1366.127200136612722025-03-31
03660812145329VYGON1362.127200136212722025-03-31
03660812145923VYGON1362.107100136210712025-03-31
03660812145930VYGON1362.107200136210722025-03-31
03660812147088VYGON1366.147100136614712025-03-31
03660812154222VYGON1362.067100136206712025-03-31
53660812094530VYGON368.47000368472025-03-31
33660812106628VYGON1366.167100136616712025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
00816777025913Sofia 5F-125cm STRMicrovention, Inc.DQO2018-08-07
00816777025920Sofia 5F-115cm STRMicrovention, Inc.DQO2018-08-07
00857688007278Respiguide Delivery SystemRESPICARDIA, INC.DQO2018-04-30
00884450089194EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00884450089200EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00866749000202Morph Universal Deflectable Guide CatheterBIOCARDIA, INC.DQO2016-10-10
08714729200567Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200574Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200598Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24