IRRAflow Tube Set ICDS 030

GUDID 10850013266200

IRRAS USA

Cerebrospinal fluid pressure regulation system, gravity-flow
Primary Device ID10850013266200
NIH Device Record Key73a1ca01-750c-45b1-b619-4c4767b38355
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRRAflow Tube Set
Version Model NumberICDS 030
Catalog NumberICDS 030
Company DUNS056999617
Company NameIRRAS USA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com
Phone800-213-4604
Emailinfo@irras.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -25 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850013266203 [Primary]
GS100850013266265 [Package]
Contains: 00850013266203
Package: Each [1 Units]
In Commercial Distribution
GS110850013266200 [Package]
Contains: 00850013266203
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

GWMDevice, Monitoring, Intracranial Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-10
Device Publish Date2023-11-02

Devices Manufactured by IRRAS USA

00850013266005 - Hummingbird Cranial Access Kit2023-12-18
00850013266227 - Hummingbird Cranial Access Kit2023-12-18
10850013266200 - IRRAflow Tube Set2023-11-10
10850013266200 - IRRAflow Tube Set2023-11-10
10850013266231 - Hummingbird2023-10-23 IC 40 Cranial Access Kit
10850013266248 - Hummingbird2023-10-23 IC42 Cranial Access Kit
00850013266104 - Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor2022-06-10 Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor
10850013266019 - Hummingbird® Patient Monitor2020-05-06 HICP200 Hummingbird Patient / Monitor Interconnect Cable
10868643000477 - IRRAflow® Drainage Collection System2020-05-06 DCS 010 Drainage Collection System
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