Identity
- Trade Name
- Arisure FDA UDI
- Generic Name
- Non-ISO80369 formatted bag access spike FDA UDI
- Device Name
- Arisure Dry Spike Non-Vented FDA UDI
- Model / Reference
- YM064 FDA UDI
- Description
- Arisure Dry Spike Non-Vented FDA UDI
Identifiers
- Catalog Number
- YM064 FDA UDI
- Primary DI / UDI-DI
- 00851891007209 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Non-ISO80369 formatted bag access spike FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Non-ISO80369 formatted bag access spike
Arisure by Yukon Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Yukon Medical, LLC
Sources (1)
- FDA UDI 50c92cb6-a58a-4578-843a-5a02d5e6fbdc 35 fields · synced May 31, 2026