Aqueduct SED

Primary DI
ACCBAG000
Brand
Aqueduct SED
Company
AQUEDUCT CRITICAL CARE, INC.
Model
ACC-BAG-100
Device description
The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF.
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
ACCBAG100PackageHIBCC10In Commercial Distribution
ACCBAG000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid pressure regulation system fluid-collection setA sterile component of a cerebrospinal fluid pressure regulation system that consists of tubing and drainage bag designed to collect the cerebrospinal fluid (CSF) on the distal side of the CSF drainage control unit/pump, to which it is attached. It is typically made of synthetic polymer material. This is a single-use device.

Regulatory Flags#

DUNS number
089176922
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ACCHLD100Aqueduct SEDACC-HLD-1002017-03-20
ACCBAG100Aqueduct SEDACC-BAG-1002017-03-20
ACCCART100Aqueduct SEDACC-CART-1002017-03-20
ACCCON100Aqueduct SEDACC-CON-1002017-04-04
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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