Aqueduct SED

Primary DI
ACCCON100
Brand
Aqueduct SED
Company
AQUEDUCT CRITICAL CARE, INC.
Model
ACC-CON-100
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.
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
ACCCON200PackageHIBCC1Not in Commercial Distribution
ACCCON100PrimaryHIBCC0

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 Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089176922
Device count
1
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
ACCKIT100Aqueduct SEDACC-KIT-100ACC-KIT-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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