Identity
- Trade Name
- Arisure FDA UDI
- Generic Name
- Non-ISO80369 formatted bag access spike FDA UDI
- Device Name
- Arisure Bag Spike FDA UDI
- Model / Reference
- YM061 FDA UDI
- Description
- Arisure Bag Spike FDA UDI
Identifiers
- Catalog Number
- YM061 FDA UDI
- Primary DI / UDI-DI
- 00851891007308 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
Yes
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
Similar devices
Also classified as Non-ISO80369 formatted bag access spike.
- ProSeal CSTD — EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- SPIKE, BLOOD W/ 1/4" CONNECTOR COVER — NOVOSCI CORP. · Class II
- SPIKE ADAPTER — B. BRAUN MEDICAL INC. · Class II
- BD PhaSeal — BD Switzerland Sàrl · Class II
- Dispensing Pin — B. BRAUN MEDICAL INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yukon Medical, LLC
Sources (1)
- FDA UDI 0b69a044-930c-4afd-8677-c8851c845252 35 fields · synced May 30, 2026