FDA.reportPublic FDA data

VYGON

Primary DI
30849884003537
Brand
VYGON
Company
Vygon Corporation
Model
AMS-949
Catalog number
AMS-949
Device description
FILTER SET
Published
2019-11-01
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
OJAIntravenous extension tubing set

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJAIntravenous Extension Tubing SetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884003537PackageGS150In Commercial Distribution
00849884003536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400353730849884003537
00849884003536008498840035368498840035360849884003536

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile 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. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, 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
10884450029364Merit Medical®Merit Medical Systems, Inc.OJA2026-03-24
10884450027339Merit Medical®Merit Medical Systems, Inc.OJA2026-03-20
20884450031234Merit Medical®Merit Medical Systems, Inc.OJA2026-03-19
20884450428188Merit Medical®Merit Medical Systems, Inc.OJA2026-03-14
10884450029203Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
10884450122560Merit Medical®Merit Medical Systems, Inc.OJA2026-03-13
20884450029668Merit Medical®Merit Medical Systems, Inc.OJA2026-03-12
20884450113688Merit Medical®Merit Medical Systems, Inc.OJA2026-03-10
20884450123458Merit Medical®Merit Medical Systems, Inc.OJA2026-03-04
20884450029262Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
10884450428884Merit Medical®Merit Medical Systems, Inc.OJA2026-03-03
10884450029807Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
10884450121778Merit Medical®Merit Medical Systems, Inc.OJA2026-02-28
20884450437340Merit Medical®Merit Medical Systems, Inc.OJA2026-02-19
10884450028169Merit Medical®Merit Medical Systems, Inc.OJA2026-02-18
10884450027384Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
20884450029019Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450121396Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450428631Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450434199Merit Medical®Merit Medical Systems, Inc.OJA2026-02-14
10884450122287Merit Medical®Merit Medical Systems, Inc.OJA2026-02-06
10884450031183Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
20884450106260Merit Medical®Merit Medical Systems, Inc.OJA2026-02-05
10884450121969Merit Medical®Merit Medical Systems, Inc.OJA2026-02-03
20884450027183Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
20884450136823Merit Medical®Merit Medical Systems, Inc.OJA2026-01-30
20884450122024Merit Medical®Merit Medical Systems, Inc.OJA2026-01-28
10884450029272Merit Medical®Merit Medical Systems, Inc.OJA2026-01-27
20884450136809Merit Medical®Merit Medical Systems, Inc.OJA2026-01-24
10884450122034Merit Medical®Merit Medical Systems, Inc.OJA2026-01-23