Identity
- Trade Name
- IV Plus® FDA UDI
- Generic Name
- Vial transfer spike FDA UDI
- Device Name
- 20mm Multi-Dose Vial Access Device FDA UDI
- Model / Reference
- N0601A FDA UDI
- Description
- 20mm Multi-Dose Vial Access Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10892855000802 FDA UDI
- 510(k) Number
- K080976 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Vial transfer spike FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not 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
IV Plus® by Nexus Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K080976 also covers:
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
- Nexus Medical, LLC
Sources (1)
- FDA UDI a2f67e17-25de-4d7b-ae6e-8e1b6c7cb75b 36 fields · synced May 30, 2026