Aqueduct SED

GUDID ACCBAG100

The Aqueduct SED Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF.

AQUEDUCT CRITICAL CARE, INC.

Cerebrospinal fluid pressure regulation system fluid-collection set Cerebrospinal fluid pressure regulation system fluid-collection set

• Primary Device ID: ACCBAG100
• NIH Device Record Key: f1526e8a-46b3-470e-b72b-24aa004d2737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aqueduct SED
• Version Model Number: ACC-BAG-100
• Company DUNS: 089176922
• Company Name: AQUEDUCT CRITICAL CARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ACCBAG000 [Primary]
HIBCC	ACCBAG100 [Package]; Contains: ACCBAG000; Package: Shelf Box [10 Units]; 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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-20

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