FDA.reportPublic FDA data

Arisure

Primary DI
00851891007360
Brand
Arisure
Company
YUKON MEDICAL, LLC
Model
YM104-05
Catalog number
YM104-05
Device description
Arisure Closed Male Luer Multipack (5-Pack)
Published
2024-12-03
Public version status
New
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
10851891007367PackageGS120In Commercial Distribution
00851891007360PrimaryGS10
20851891007364Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085189100736710851891007367
00851891007360008518910073608518910073600851891007360
2085189100736420851891007364

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
963361170
Device count
5
Lot or batch
true
Manufacturing date on label
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
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
10885403232671NoneMV0613MV06132017-07-07

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Primary DI, Brand, Company table
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00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
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05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15