FDA.reportPublic FDA data

Arisure

Primary DI
00851891007117
Brand
Arisure
Company
YUKON MEDICAL, LLC
Model
YM007
Catalog number
YM007
Device description
Arisure Closed Male Luer
Published
2018-10-22
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
FPASet, Administration, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50851891007112PackageGS1100In Commercial Distribution
00851891007117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085189100711250851891007112
00851891007117008518910071178518910071170851891007117

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure intravenous line needleless valve-connectorA small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point negative pressure from the device causes a small volume of retrograde fluid flow into the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
919-595-8250Quality@YukonMedical.com

Regulatory Flags#

DUNS number
963361170
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851891007070ViaLokYM011YM0112016-09-23
00851891007292ArisureYM060YM0602025-05-14
00851891007605ArisureYM060YM0602025-06-30
20851891007609ArisureYM060YM0602025-06-30
00851891007629ArisureYM062YM0622025-05-23
20851891007623ArisureYM062YM0622025-05-23
00851891007308ArisureYM061YM0612025-05-14
10851891007299ArisureYM060YM0602025-05-14
10851891007305ArisureYM061YM0612025-05-14
00851891007360ArisureYM104-05YM104-052024-12-03
00851891007322ArisureYM106YM1062024-11-27
00851891007353ArisureYM107YM1072024-11-27
10851891007329ArisureYM106YM1062024-11-27
10851891007350ArisureYM107YM1072024-11-27
10885403228100SmartSiteMV0513MV05132017-04-03
10885403228445SmartSiteMV0413MV04132017-02-07
10885403228452SmartSiteMV0420MV04202016-09-22
10885403228469SmartSiteMV0428MV04282017-04-06
10885403229022SmartSiteMV0528MV05282017-04-06
10885403232664NoneMV0620MV06202017-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101258Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06
00634624101302Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06