FDA.reportPublic FDA data

DYEVERT™ PLUS EZ

Primary DI
00815241020799
Brand
DYEVERT™ PLUS EZ
Company
OSPREY MEDICAL INC.
Model
HV-EZ-PWL
Device description
DyeVert Plus EZ Contrast Reduction System
Published
2018-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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
00815241020799PackageGS110In Commercial Distribution
00815241020638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815241020799008152410207998152410207990815241020799
00815241020638008152410206388152410206380815241020638

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
9529558249dshertok@ospreymed.com

Regulatory Flags#

DUNS number
938215568
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
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
00815241020195DYEVERT™ PLUSLVOFF-PWL2017-11-28
00815241020201DYEVERT™ PLUSLVOFF-RRS2017-03-13
00815241020218DYEVERT™ PLUSLVOFF-PRS2018-01-17
00815241020423DYETECT™ Contrast Monitoring Disposable KitPWL2018-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841716103657AngioTouch Module (15')ACIST MEDICAL SYSTEMS, INC.DXT2026-06-08
10841716104296ACIST Pro Diagnostic SystemACIST MEDICAL SYSTEMS, INC.DXT2026-06-07
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