IRRAflow® ICCU 020

GUDID 10868643000408

IRRAS USA

Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow Cerebrospinal fluid pressure regulation system, gravity-flow

• Primary Device ID: 10868643000408
• NIH Device Record Key: bb0341f3-8534-442d-b153-a86a48f16122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRAflow®
• Version Model Number: ICCU 020
• Catalog Number: ICCU 020
• Company DUNS: 056999617
• Company Name: IRRAS USA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868643000401 [Primary]
GS1	10868643000408 [Package]; Contains: 00868643000401; Package: Bov [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171880

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

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: 2019-02-22
• Device Publish Date: 2019-01-22

Devices Manufactured by IRRAS USA

• 00850013266005 - Hummingbird Cranial Access Kit: 2023-12-18
• 00850013266227 - Hummingbird Cranial Access Kit: 2023-12-18
• 10850013266200 - IRRAflow Tube Set: 2023-11-10
• 10850013266231 - Hummingbird: 2023-10-23 IC 40 Cranial Access Kit
• 10850013266248 - Hummingbird: 2023-10-23 IC42 Cranial Access Kit
• 00850013266104 - Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor: 2022-06-10 Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor
• 10850013266019 - Hummingbird® Patient Monitor: 2020-05-06 HICP200 Hummingbird Patient / Monitor Interconnect Cable
• 10868643000477 - IRRAflow® Drainage Collection System: 2020-05-06 DCS 010 Drainage Collection System