FDA.reportPublic FDA data

IRRAflow®

Primary DI
00868643000401
Brand
IRRAflow®
Company
Clearpoint Neuro, Inc.
Model
ICCU 020
Catalog number
ICCU 020
Published
2019-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868643000408PackageGS11In Commercial Distribution
00868643000401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086864300040810868643000408
00868643000401008686430004018686430004010868643000401

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid pressure regulation system, gravity-flowAn assembly of electronic devices designed to simultaneously monitor cerebrospinal fluid (CSF) pressure and drain CSF at a rate regulated by the desired intracranial or in-tube CSF pressure. It consists of a control unit, a user interface, and provides CSF drainage via gravity; it is connected to disposable tubing/collection bags and a dedicated CSF access device (e.g., catheter, needle) inserted into the cerebral ventricles or subarachnoid (intrathecal) space of the spinal column. It is typically used in head trauma, normal pressure hydrocephalus (NPH) diagnostics, and during major vascular surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-213-4604info@irras.com

Regulatory Flags#

DUNS number
119078557
Device count
1
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013266012Hummingbird® Patient MonitorHICP200HICP2002019-10-14
00850013266029Hummingbird® SynergyDuoH610H6102019-10-10
00850013266036Hummingbird® Parenchymal CatheterH110H1102019-10-10
00850013266180Hummingbird® Cranial Access Kit IC42-DIC42-D2020-01-29
00850013266197Hummingbird® Cranial Access KitIC42IC422020-01-29
00850013266203IRRAflow Tube SetICDS 030ICDS 0302023-11-02
00850013266234HummingbirdCK 402023-10-13
00850013266241HummingbirdCK 422023-10-13
00850013266272IRRAflow Cranial Access BoltICB 0102025-07-24
00868643000463IRRAflow Laser Leveler PackageICLS 010ICLS 0102024-06-10
00868643000470IRRAflow Drainage Collection SystemDCS 010DCS 0102019-09-30
00868643000487Hummingbird® Cranial Access KitIC40DIC40-D2019-10-10
00868643000494Hummingbird® Cranial Access KitIC40IC402019-10-10
00850013266258IRRAflow Catheter 2.0+ICAT 0302025-05-07
00850013266005Hummingbird Cranial Access KitIC40IC402023-12-08
00850013266227Hummingbird Cranial Access KitIC422023-12-08
00850013266104Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor700033270003322020-05-28
00868643000418IRRAflow® Cassette and Tube SetICDS 020ICDS 0202019-01-22
00868643000425IRRAflow® 1.5 CatheterICGS 010ICGS 0102019-01-22
00868643000432IRRAflow® 2.0 CatheterICGS 020ICGS 0202019-01-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409440285SophysaSOPHYSAJXG2026-06-22
03760409440308SophysaSOPHYSAJXG2026-06-22
03760409440315SophysaSOPHYSAJXG2026-06-22
03760409440322SophysaSOPHYSAJXG2026-06-22
03760409447055SOPHYSASOPHYSAGWM2026-06-08
03760409447093SOPHYSASOPHYSAGWM2026-06-08
03760409441121SophysaSOPHYSAJXG2026-06-05
03760409441138SophysaSOPHYSAJXG2026-06-05
03760409441145SophysaSOPHYSAJXG2026-06-05
03760409441152SophysaSOPHYSAJXG2026-06-05
03760409441169SophysaSOPHYSAJXG2026-06-05
03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
03760409441213SophysaSOPHYSAJXG2026-06-05
03760409441220SophysaSOPHYSAJXG2026-06-05
03760409441237SophysaSOPHYSAJXG2026-06-05
03760409441244SophysaSOPHYSAJXG2026-06-05
03760409441251SophysaSOPHYSAJXG2026-06-05
03760409441268SophysaSOPHYSAJXG2026-06-05
07908398200008BraincareBRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA SAGWM2026-05-08
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20763000467382NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.JXG2024-02-26
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.JXG2022-03-10
00763000624804Duet®MEDTRONIC PS MEDICAL, INC.JXG2022-03-10
00763000624804Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10