FDA.reportPublic FDA data

IRRAflow® Cassette and Tube Set

Primary DI
00868643000418
Brand
IRRAflow® Cassette and Tube Set
Company
Clearpoint Neuro, Inc.
Model
ICDS 020
Catalog number
ICDS 020
Published
2019-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171880000IRRAflow CNS SystemIrras, Inc.2018-07-13JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10868643000415PackageGS15In Commercial Distribution
00868643000418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086864300041510868643000415
00868643000418008686430004188686430004180868643000418

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 Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
119078557
Device count
1
Lot or batch
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
00868643000401IRRAflow®ICCU 020ICCU 0202019-01-22
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
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
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