KIRO Oncology US

GUDID 08437014572209

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.

KIRO GRIFOLS SL.

Intravenous solution compounder

• Primary Device ID: 08437014572209
• NIH Device Record Key: 4141509a-40d4-45d1-a8cd-ed08016b74e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIRO Oncology US
• Version Model Number: 1008US
• Company DUNS: 464246224
• Company Name: KIRO GRIFOLS SL.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014572209 [Primary]

FDA Product Code

• NEP: System/Device, Pharmacy Compounding

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-09-10
• Device Publish Date: 2016-11-11

Devices Manufactured by KIRO GRIFOLS SL.

• 08437014572100 - KIRO Set: 2024-09-10 The KIRO SET is a sterile, single-use, disposable ancillary device used with the peristaltic pumps in the KIRO Oncology pharmacy
• 08437014572209 - KIRO Oncology US: 2024-09-10KIRO 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.
• 08437014572209 - KIRO Oncology US: 2024-09-10 KIRO Oncology is an automated pharmacy compounding device (PCD) for the preparation of compounded sterile preparations (CSPs). K
• 08437014572308 - KIRO Link: 2024-09-10 KIRO Link is a software intended to enter, store, convert, transfer and display the data to support the integration and workflow
• 08437014572223 - KIRO Fill US: 2019-12-24 KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations