Aqueduct SED - The Aqueduct SED Cartridge is part of the - AQUEDUCT CRITICAL CARE, INC.

Duns Number:089176922

Device Description: The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interfaces with the Aqueduct SED Console for monitoring of intracranial pressure (ICP) and draining and monitoring of CSF flow from the lateral ventricles.

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More Product Details

Catalog Number

-

Brand Name

Aqueduct SED

Version/Model Number

ACC-CART-101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JXG

Product Code Name

Shunt, Central Nervous System And Components

Device Record Status

Public Device Record Key

e93cce81-5895-4e36-8675-f0258690da1c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AQUEDUCT CRITICAL CARE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11