AccessGUDID - DEVICE: IRRAflow Catheter 2.0+ (00850013266258)

GUDID

Device Identifier (DI) Information

Brand Name: IRRAflow Catheter 2.0+
Version or Model: ICAT 030
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Irras USA, Inc.

Primary DI Number: 00850013266258
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056999617 *Terms of Use

Device Description: IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, Central Nervous System And Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231664	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e7c7ec5a-e4d3-467b-b866-bf52f58599e6
Public Version Date: May 15, 2025
Public Version Number: 1
DI Record Publish Date: May 07, 2025