KIRO Fill US

GUDID 08437014572223

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.

KIRO GRIFOLS SL.

Pharmaceutical fluid-dispensing system

• Primary Device ID: 08437014572223
• NIH Device Record Key: de611c11-5dbf-4cd1-9429-6e9ac6deccb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIRO Fill US
• Version Model Number: 1002US
• 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: 1-800-379-0957
• Email: HospitalUSService@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
• Phone: 1-256-500-4339
• Email: supportkirousa@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014572223 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-24
• Device Publish Date: 2019-12-16

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: 2024-09-10 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: 2019-12-24KIRO 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.
• 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