Aqueduct SED

Primary DI
ACCBAG100
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
089176922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ACCHLD100Aqueduct SEDACC-HLD-1002017-03-20
ACCBAG000Aqueduct 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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