Aqueduct SED

DI: ACCCON100 · Model: ACC-CON-100 · AQUEDUCT CRITICAL CARE, INC.

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

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Basic Information

Brand Name: Aqueduct SED
Primary DI: ACCCON100
Version / Model: ACC-CON-100
Company Name: AQUEDUCT CRITICAL CARE, INC.
Labeler DUNS: 089176922
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-04-04
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: 11a5bb11-cace-462a-a6ce-4d7796b7cf89
Distribution End Date: 2017-09-27

Device Description

The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Unsafe
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, Central Nervous System And Components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62640	Cerebrospinal fluid pressure regulation system, gravity-flow	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ACCCON100	HIBCC
Package	ACCCON200	HIBCC	Service Console	1	Not in Commercial Distribution	2017-09-27

Premarket Submissions

Submission Number	Supplement Number
K161605	000

Storage Conditions

Type: Handling Environment Humidity
Temperature Range: – 75 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 15 – 30 Degrees Celsius