Identity
- Trade Name
- KIRO Oncology US FDA UDI
- Generic Name
- Intravenous solution compounder FDA UDI
- Device Name
- KIRO Oncology is an automated pharmacy compounding device (PCD) for the preparation of compounded sterile preparations (CSPs). KIRO Oncology includes an automated cleaning system for decontamination of the compounding area. The device is intended to be used only by qualified pharmacy personnel. FDA UDI
- Model / Reference
- 1008US FDA UDI
- Description
- KIRO Oncology is an automated pharmacy compounding device (PCD) for the preparation of compounded sterile preparations (CSPs). KIRO Oncology includes an automated cleaning system for decontamination of the compounding area. The device is intended to be used only by qualified pharmacy personnel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437014572209 FDA UDI
- FDA Product Code
- NEP FDA UDI
- GMDN Term
- Intravenous solution compounder 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravenous solution compounder
KIRO Oncology US by Kiro Grifols Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous solution compounder.
- EXACTAMIX — Baxter Healthcare Corp · Class II
- EXACTAMIX — Baxter Healthcare Corp · Class II
- i.v.STATION — HEALTH ROBOTICS SRL · Class II
- ABACUS — Baxter Healthcare Corp · Class II
- EXACTAMIX — Baxter Healthcare Corp · Class II
- PINNACLE® — B. BRAUN MEDICAL INC. · Class II
- EXACTAMIX — Baxter Healthcare Corp · Class II
- PINNACLE® — 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
- Kiro Grifols Sl.
Sources (1)
- FDA UDI 4141509a-40d4-45d1-a8cd-ed08016b74e1 34 fields · synced May 30, 2026