FDA.reportPublic FDA data

VYGON

Primary DI
00849884007510
Brand
VYGON
Company
Vygon Corporation
Model
VYML4S3001A-1
Catalog number
VYML4S3001A-1
Device description
4Fr x 20cm Single Lumen Midline Max Barrier Kit
Published
2026-05-22
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
PNDMidline catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNDMidline CatheterGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181208000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181208000Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA2018-11-02PND

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884007511PackageGS14In Commercial Distribution
00849884007510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400751130849884007511
00849884007510008498840075108498840075100849884007510

GMDN Terms#

Term, Definition table
TermDefinition
Centrally-inserted central venous catheterA flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. 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
false
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
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
30849884007191VYGONAMS-2008AMS-20082025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007527VYGONVygon CorporationPND2026-05-22
50884908185718CT MIDLINE CATHETERMedical Components, Inc.PND2026-01-15
30849884007030VYGONVygon CorporationPND2025-09-26
30849884007047VYGONVygon CorporationPND2025-09-25
30849884006941VYGONVygon CorporationPND2025-09-15
30849884007009VYGONVygon CorporationPND2025-09-05
30849884006996VYGONVygon CorporationPND2025-08-21
10801741236140ProvenaBard Access Systems, Inc.PND2025-08-20
10801741236157ProvenaBard Access Systems, Inc.PND2025-08-20
10801741236836PowerMidlineBard Access Systems, Inc.PND2025-08-20
10801741234849Provena MidlineBard Access Systems, Inc.PND2025-01-23
10801741234566PowerMidlineBard Access Systems, Inc.PND2024-12-09
10801741234597Provena MidlineBard Access Systems, Inc.PND2024-12-09
10801741232135PowerMidlineBard Access Systems, Inc.PND2024-09-27
10801741232142Bard PowerMidlineBard Access Systems, Inc.PND2024-09-27
10801741233224Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233231Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233248Provena MidlineBard Access Systems, Inc.PND2024-09-27
10801741233255Provena MidlineBard Access Systems, Inc.PND2024-09-27
20801902213062ARROWTELEFLEX INCORPORATEDPND2024-08-01
20801902213086ARROWTELEFLEX INCORPORATEDPND2024-08-01
1085004236505920G 8CM Stiletto Extended Dwell CatheterAvia Vascular, LLCPND2024-06-25
0085005184200120G 8CM Stiletto Extended Dwell CatheterSlipstream Medical, LLCPND2024-02-05
20801902218869ARROWTELEFLEX INCORPORATEDPND2024-01-29
20801902218852ARROWTELEFLEX INCORPORATEDPND2024-01-24
10801741226943PowerMidlineBard Access Systems, Inc.PND2023-09-19
20801902216827ARROWTELEFLEX INCORPORATEDPND2023-09-13
20801902216834ARROWTELEFLEX INCORPORATEDPND2023-09-13
10801741227544ProvenaBard Access Systems, Inc.PND2023-07-10
10801741226868PowerGlide STBard Access Systems, Inc.PND2023-07-05