Aqueduct SED

GUDID ACCCON100

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

AQUEDUCT CRITICAL CARE, INC.

Cerebrospinal fluid pressure regulation system, gravity-flow

• Primary Device ID: ACCCON100
• NIH Device Record Key: 11a5bb11-cace-462a-a6ce-4d7796b7cf89
• Commercial Distribution Discontinuation: 2017-09-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aqueduct SED
• Version Model Number: ACC-CON-100
• Company DUNS: 089176922
• Company Name: AQUEDUCT CRITICAL CARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ACCCON100 [Primary]
HIBCC	ACCCON200 [Package]; Package: Service Console [1 Units]; Discontinued: 2017-09-27; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161605

FDA Product Code

• JXG: Shunt, Central Nervous System And Components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-04

On-Brand Devices [Aqueduct SED]

• ACCKIT101: The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aque
• ACCCON101: The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial press
• ACCCART101: The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
• ACCKIT200: The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aque
• ACCCONS200: The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial press
• ACCCARTV101: The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
• ACCCARTL200: The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
• ACCKIT100: The Aqueduct Smart External Drain Kit is a convenience kit of the re-usable portions of the Aque
• ACCCON100: The Aqueduct SED Console is part of the Aqueduct SED System for monitoring of intracranial press
• ACCCART100: The Aqueduct SED Cartridge is part of the Aqueduct SED System. This disposable tubing set interf
• ACCBAG100: The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF.
• ACCHLD100: The Aqueduct SED Drain Bag Holder interfaces with the Aqueduct SED Drain Bag (ACCBAG000) when in