FDA.reportPublic FDA data

KIRO Oncology US

Primary DI
08437014572209
Brand
KIRO Oncology US
Company
KIRO GRIFOLS SL.
Model
1008US
Device 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.
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEPSystem/Device, Pharmacy Compounding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEPSystem/Device, Pharmacy CompoundingGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437014572209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437014572209084370145722098437014572209

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous solution compounderA device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-256-500-4339supportkirousa@grifols.com

Regulatory Flags#

DUNS number
464246224
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437014572100KIRO Set1008012016-11-11
08437014572308KIRO Link10062018-11-07
08437014572223KIRO Fill US1002US2019-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887709098602ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-05-28
00887709166288ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166295ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709166318ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709170988ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-16
00887709127371ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127388ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127395ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-04-01
00887709127432ICU Medical, IncICU MEDICAL, INC.NEP2026-04-01
00887709125995ICU Medical, Inc.ICU MEDICAL, INC.NEP2026-01-12
00887709167216ICU Medical, Inc.ICU MEDICAL, INC.NEP2025-10-20
00860001977356OnsetOnpharma CompanyNEP2025-09-19
00085412169286DUO-VENTBaxter Healthcare SANEP2025-03-20
50085412169281DUO-VENTBaxter Healthcare SANEP2025-03-20
00860006285043IVX ManagerOmnicell, Inc.NEP2024-05-10
00840619054908DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619065058DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619089894DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619090876DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00840619091590DianaTM Automated Drug Compounding SystemICU MEDICAL, INC.NEP2024-02-20
00850033629408Acta MedicalActa Medical LLCNEP2024-02-14
00860006285036IVX CloudOmnicell, Inc.NEP2024-01-10
08426314948258GRI-FILLLABORATORIOS GRIFOLS SANEP2023-07-19
00887709125117DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125124DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125131DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709125735DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126497DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126589DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10
00887709126596DianaTM Compounding Workflow SystemICU MEDICAL, INC.NEP2023-04-10