Identity
- Trade Name
- Arisure EUDAMEDFDA UDI
- Generic Name
- Non-ISO80369 formatted bag access spike FDA UDI
- Device Name
- Arisure Dry Spike EUDAMEDFDA UDI
- Model / Reference
- Arisure EUDAMEDYM050 EUDAMEDFDA UDI
- Description
- Arisure Dry Spike FDA UDI
Identifiers
- Catalog Number
- YM050 FDA UDI
- Primary DI / UDI-DI
- 00851891007124 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00851891007124 EUDAMED
- FDA Product Code
- LHI FDA UDI
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
- GMDN Term
- Non-ISO80369 formatted bag access spike FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Arisure by Yukon Medical, LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00851891007124 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Yukon Medical, LLC
- EUDAMED SRN
- US-MF-000027131
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8244e23c-dd4a-438e-a7cf-0a7195229fb7 61 fields · synced Jul 9, 2026
- FDA UDI 1487a68f-257b-4b81-8e23-be1b3561d5d9 35 fields · synced May 29, 2026