FDA.reportPublic FDA data

Arisure

Primary DI
00851891007308
Brand
Arisure
Company
YUKON MEDICAL, LLC
Model
YM061
Catalog number
YM061
Device description
Arisure Bag Spike
Published
2025-05-14
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
LHISet, I.V. Fluid Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHISet, I.V. Fluid TransferGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851891007305PackageGS150In Commercial Distribution
20851891007302PackageGS14In Commercial Distribution
00851891007308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085189100730510851891007305
2085189100730220851891007302
00851891007308008518910073088518910073080851891007308

GMDN Terms#

Term, Definition table
TermDefinition
Non-ISO80369 formatted bag access spikeA small, noninvasive, tubular connector with a small-bore connection/port, none of which is designed according to ISO 80369 (non-ISO80369 formatted), and a hollow bag-access spike (either blunt or sharp) intended to connect an intravenous (IV) fluid or blood bag to a fluid line for administration to a patient. It may include a built-in air filter and drip chamber; it does not include tubing (i.e., not a tubing set) or any Luer formatted connections. 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
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
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
10885403232671NoneMV0613MV06132017-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08699443581898FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581911FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443581928FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585292FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585308FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585315FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585322FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
08699443585339FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2026-02-13
10815879021929IV PlusNEXUS MEDICAL, LLCLHI2025-10-03
10815879021806 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-10-21
08699443580174FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-10-07
10815879021783IV PlusNEXUS MEDICAL, LLCLHI2024-09-27
10815879021745IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
10815879021752IV PlusNEXUS MEDICAL, LLCLHI2024-09-16
08699443580167FlowArt®ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETILHI2024-08-05
10815879021677 Nexus TKO®NEXUS MEDICAL, LLCLHI2024-04-02
10197344001699MedlineMEDLINE INDUSTRIES, INC.LHI2024-03-05
10815879021660IV PlusNEXUS MEDICAL, LLCLHI2024-03-05
10860009080505NavaClick Injection KitLineage Biomedical, Inc.LHI2024-01-30
10815879021547IV PlusNEXUS MEDICAL, LLCLHI2022-09-08
10193489896848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LHI2022-08-04
10815879021523IV PlusNEXUS MEDICAL, LLCLHI2022-06-15
10612479261959McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
10612479261973McKessonMCKESSON MEDICAL-SURGICAL INC.LHI2022-02-24
08426314778770GRI-FILL 6 to1 SetLABORATORIOS GRIFOLS SALHI2021-10-25
10815879021394IV PlusNEXUS MEDICAL, LLCLHI2021-02-26
10815879021295IV PlusNEXUS MEDICAL, LLCLHI2021-01-20
10850022888011Vial2Bag Advanced 20mmWest Pharmaceutical Services Az, Inc.LHI2020-12-23
10813153020330CodanCodan US CorporationLHI2017-11-30
10813153020316CodanCodan US CorporationLHI2017-10-31