FDA.reportPublic FDA data

DYEVERT™ PLUS

Primary DI
00815241020195
Brand
DYEVERT™ PLUS
Company
OSPREY MEDICAL INC.
Model
LVOFF-PWL
Device description
DyeVert Plus Contrast Reduction System
Published
2017-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815241020195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815241020195008152410201958152410201950815241020195

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium conservation systemAn assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9529558247vfabano@ospreymed.com

Regulatory Flags#

DUNS number
938215568
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815241020416DYETECT™ Contrast Monitoring Disposable KitRRL2020-12-01
00815241020430DYETECT™ Contrast Monitoring Disposable KitPRL2020-12-01
00815241020485SMART SYRINGER-RRL2020-12-01
00815241020492SMART SYRINGER-PRL2020-12-01
00815241021031DYEVERT™ PLUS EZHV-EZ-RRL2020-12-01
00815241021048DYEVERT™ PLUS EZLV-EZ-RRL2020-12-01
00815241021055DYEVERT™ PLUS EZLV-EZ-PRL2020-12-01
00815241021062DYEVERT™ PLUS EZHV-EZ-PRL2020-12-01
00815241020829Smart MonitorSMART2019-10-29
00815241020638DYEVERT™ PLUS EZHV-EZ-PWL2018-11-09
00815241020645DYEVERT™ PLUS EZLV-EZ-PWL2018-11-09
00815241020713DYEVERT™ PLUS EZHV-EZ-PRS2018-11-09
00815241020720DYEVERT™ PLUS EZLV-EZ-PRS2018-11-09
00815241020133DYEVERT™ PLUSHVOFF-PWL2017-11-28
00815241020140DYEVERT™ PLUSHVOFF-RRS2017-03-13
00815241020157DYEVERT™ PLUSHVOFF-PRS2017-08-17
00815241020201DYEVERT™ PLUSLVOFF-RRS2017-03-13
00815241020218DYEVERT™ PLUSLVOFF-PRS2018-01-17
00815241020423DYETECT™ Contrast Monitoring Disposable KitPWL2018-02-23
00815241020447DYETECT™ Contrast Monitoring Disposable KitRRS2017-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDDXT2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-12-10
10193489065824NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066029NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066043NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
10193489066081NAMICMEDLINE INDUSTRIES, INC.DXT2025-05-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDDXT2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDDXT2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDDXT2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDDXT2025-03-28
10193489065831NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065916NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066067NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066104NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066142NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489066159NAMICMEDLINE INDUSTRIES, INC.DXT2024-07-08
10193489065848NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065855NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065886NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065893NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065923NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065930NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065947NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065954NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065961NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065978NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065985NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489065992NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066005NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05
10193489066012NAMICMEDLINE INDUSTRIES, INC.DXT2024-03-05