Identity
- Trade Name
- KIRO Set FDA UDI
- Generic Name
- Compounding transfer set FDA UDI
- Device Name
- The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration. FDA UDI
- Model / Reference
- 100801 FDA UDI
- Description
- The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy compounding device for the transfer of fluids into sterile powder drug vials for reconstitution of intravenous drugs or into sterile medication containers for intravenous drug administration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437014572100 FDA UDI
- 510(k) Number
- K152441 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Compounding transfer set 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
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
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: Compounding transfer set
KIRO Set by Kiro Grifols Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Compounding transfer set.
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- IVX Station Stock Solution Transfer Set — Omnicell, Inc. · Class II
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- ICU Medical — ICU MEDICAL, INC. · Class II
- B.BRAUN — 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 |
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Manufacturer
- Manufacturer
- Kiro Grifols Sl.
Sources (1)
- FDA UDI 10260b7f-fcac-47b8-bbbb-715832102e40 35 fields · synced May 30, 2026