KIRO GRIFOLS SL.

Address:Poligono Industrial Bainetxe, Pab 5A,Aretxabaleta Guipuzcoa,ES

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System/Device, Pharmacy Compounding (NEP) (2) Medical Device Data System (OUG) (1) Set, I.V. Fluid Transfer (LHI) (1)

Premarket Exempt

No Yes

Clear

KIRO Set - 08437014572100 Catalog Number :

Device Description : The KIRO SET is a sterile, single-use, disposable ancillary device used with the 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.

Device Class :

Duns Number: 464246224

Premarket Exempt : No

Product Code : LHI

Prescription Use : No

Device Count : 1

KIRO Oncology US - 08437014572209 Catalog Number :

Device Description : KIRO Oncology is an automated pharmacy compounding device (PCD) for the preparat 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.

Device Class : 2

Duns Number: 464246224

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

KIRO Fill US - 08437014572223 Catalog Number :

Device Description : KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations (CSPs). The device is intended to be used only by qualified pharmacy personnel.

Device Class : 2

Duns Number: 464246224

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

KIRO Link - 08437014572308 Catalog Number :

Device Description : KIRO Link is a software intended to store, convert formats, transfer and display KIRO Link is a software intended to store, convert formats, transfer and display the medical data required for the integration and workflow management functionalities of compounding associated technologies. These technologies include customer site software (Computerized Physician Order Entry (CPOE), logistics, quality control, etc.), Pharmacy Compounding Devices (PCDs) and compounding assisting software. The software is intended to be used only by qualified pharmacy personnel.

Device Class : 1

Duns Number: 464246224

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

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