IRRAflow® Cassette and Tube Set ICDS 020

GUDID 00868643000418

Cerebrospinal fluid pressure regulation system, gravity-flow

Primary Device ID	00868643000418
NIH Device Record Key	f78b0e13-a300-4e7a-833f-24b25f9d4eb2
Commercial Distribution Status	In Commercial Distribution
Brand Name	IRRAflow® Cassette and Tube Set
Version Model Number	ICDS 020
Catalog Number	ICDS 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	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	true
RX Perscription	true
OTC Over-The-Counter	false

Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between -25 Degrees Celsius and 50 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00868643000418 [Primary]
GS1	10868643000415 [Package] Package: Box [5 Units] In Commercial Distribution

GWM	Device, Monitoring, Intracranial Pressure

Steralize Prior To Use	false
Device Is Sterile	true

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

Mark Image Registration \| Serial	Company Trademark Application Date
IRRAFLOW 87161655 5492869 Live/Registered	Irras AB 2016-09-06