Aqueduct SED

Primary DI
ACCKIT100
Brand
Aqueduct SED
Company
AQUEDUCT CRITICAL CARE, INC.
Model
ACC-KIT-100
Catalog number
ACC-KIT-100
Device description
The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aqueduct SED System. The Aqueduct SED system is a collection of devices for Monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.This kit contains ACCCON100 and ACCHLD100.
Published
2017-04-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161605000Smart External Drain (SED) SystemAqueduct Critical Care, Inc.2016-10-27JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ACCKIT100PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089176922
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ACCHLD100Aqueduct SEDACC-HLD-1002017-03-20
ACCBAG000Aqueduct SEDACC-BAG-1002017-03-20
ACCBAG100Aqueduct SEDACC-BAG-1002017-03-20
ACCCART100Aqueduct SEDACC-CART-1002017-03-20
ACCCON100Aqueduct SEDACC-CON-1002017-04-04
ACCCARTL200Aqueduct SEDACC-CART-200L2018-04-01
ACCCARTV101Aqueduct SEDACC-CART-101V2018-04-01
ACCCONS200Aqueduct SEDACC-CON-2002018-04-01
ACCKIT200Aqueduct SEDACC-KIT-2002018-04-01
ACCCART101Aqueduct SEDACC-CART-1012017-09-27
ACCCON101Aqueduct SEDACC-CON-1012017-09-27
ACCKIT101Aqueduct SEDACC-KIT-1012017-09-27

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