KIRO Fill US

Basic Information

• Brand Name: KIRO Fill US
• Primary DI: 08437014572223
• Version / Model: 1002US
• Company Name: KIRO GRIFOLS SL.
• Labeler DUNS: 464246224
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-16
• Public Version: 1
• Public Version Date: 2019-12-24
• Public Version Status: New
• Public Device Record Key: de611c11-5dbf-4cd1-9429-6e9ac6deccb8

Device Description

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 Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEP	System/Device, Pharmacy Compounding	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16807	Pharmaceutical fluid-dispensing system	A assembly of devices used in a hospital and/or other healthcare facility to dispense fluids by combining in a given ratio several liquid components from a set of source containers into a container with the final product (i.e., it compounds drugs according to a specified medical prescription). It is typically a mains electricity (AC-powered) automated or semi-automated device that includes a set of standardized source liquid containers each attached with tubes to a compounding device which output is in turn attached to the final liquid container. It may also include a control panel to facilitate the introduction of manual or bar-coded mixing and/or checking instructions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437014572223	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]