KIRO Set

GUDID 08437014572100

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.

KIRO GRIFOLS SL.

Compounding transfer set

• Primary Device ID: 08437014572100
• NIH Device Record Key: 10260b7f-fcac-47b8-bbbb-715832102e40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIRO Set
• Version Model Number: 100801
• Company DUNS: 464246224
• Company Name: KIRO GRIFOLS SL.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08437014572100 [Primary]
GS1	08437014572117 [Package]; Package: Shelf Box [10 Units]; In Commercial Distribution
GS1	18437014572107 [Package]; Package: Shipper Box [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152441

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-09-10
• Device Publish Date: 2016-11-11

Devices Manufactured by KIRO GRIFOLS SL.

• 08437014572100 - KIRO Set: 2024-09-10The 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.
• 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: 2019-12-24 KIRO Fill is an automated pharmacy compounding device (PCD) for the preparation of non-hazardous Compounded Sterile Preparations