FDA.reportPublic FDA data

MANIFOLD

Primary DI
00850004162033
Brand
MANIFOLD
Company
VALFLUX GROUP, LLC
Model
VGAM0401
Catalog number
VGAM0401
Device description
VGAM0401 MANIFOLD
Published
2018-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004162033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004162033008500041620338500041620330850004162033

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system manifold kitA collection of sterile devices designed to provide an interface between a contrast medium injection system and an angiographic patient catheter for the delivery of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is intended to maximize the creation of the optimal connection for fluid delivery. It typically consists of an injection fitting that is connected to the contrast medium injection system, a pressure transducer cartridge, a check valve and tubing; it is typically made of plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+556230916442regulacao@valflux.com.br

Regulatory Flags#

DUNS number
050193715
Device count
1
Premarket exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004162217SELDINGER NEEDLEVGSN03VGSN032018-12-19
00850004162224SELDINGER NEEDLEVGSN03AVGSN03A2018-12-19
00850004162231SELDINGER NEEDLEVGSN06VGSN062018-12-19
00850004162125INTRODUCER SETVGCTR03VGCTR032018-12-20
00850004162132INTRODUCER SETVGCTR03AVGCTR03A2018-12-20
00850004162149INTRODUCER SETVGCTR04VGCTR042018-12-20
00850004162156INTRODUCER SETVGCTR04AVGCTR04A2018-12-20
00850004162163INTRODUCER SETVGHIS00VGHIS002018-12-20
00850004162170INTRODUCER SETVGHIS01VGHIS012018-12-20
00850004162187INTRODUCER SETVGHIS02VGHIS022018-12-20
00850004162194INTRODUCER SETVGHIS03VGHIS032018-12-20
00850004162200INTRODUCER SETVGHIS04VGHIS042018-12-20
00850004162248TRANSRADIAL PRESSURE BANDAGEVGPB04AVGPB04A2018-12-19
00850004162255TRANSRADIAL PRESSURE BANDAGEVGPB04BVGPB04B2018-12-19
00850004162019MANIFOLDVGAM0201VGAM02012018-12-19
00850004162026MANIFOLDVGAM0301VGAM03012018-12-19
00850004162040INFLATION DEVICEVGAI25CVGAI25C2018-12-19
00850004162057Y CONNECTOR KITVGYCK113FVGYCK113F2018-12-19
00850004162064HIGH PRESSURE TUBINGVGPMT0501VGPMT05012018-12-18
00850004162071HIGH PRESSURE TUBINGVGPMT0502VGPMT05022018-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489059199NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
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10193489059175NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064506NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064537NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059144NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059168NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059182NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064483NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064490NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064513NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064544NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064551NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064568NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489058819NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058840NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058857NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058864NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058871NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058932NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058949NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058970NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
H965814001240NAMICANGIODYNAMICS, INC.DTL2020-11-03
07613327459210AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDTL2018-10-26
07613327459180AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459197AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08
07613327459203AXS INFINITY LS PLUSStryker CorporationDTL2018-10-08