AccessGUDID - DEVICE: Aqueduct SED (ACCCON100)

GUDID

Device Identifier (DI) Information

Brand Name: Aqueduct SED
Version or Model: ACC-CON-100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AQUEDUCT CRITICAL CARE, INC.

Primary DI Number: ACCCON100
Issuing Agency: HIBCC
Commercial Distribution End Date: September 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 089176922 *Terms of Use

Device Description: 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 the lateral ventricles.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62640	Cerebrospinal fluid pressure regulation system, gravity-flow	An assembly of electronic devices designed to simultaneously monitor cerebrospinal fluid (CSF) pressure and drain CSF at a rate regulated by the desired intracranial or in-tube CSF pressure. It consists of a control unit, a user interface, and provides CSF drainage via gravity; it is connected to disposable tubing/collection bags and a dedicated CSF access device (e.g., catheter, needle) inserted into the cerebral ventricles or subarachnoid (intrathecal) space of the spinal column. It is typically used in head trauma, normal pressure hydrocephalus (NPH) diagnostics, and during major vascular surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, Central Nervous System And Components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161605	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: less than 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 11a5bb11-cace-462a-a6ce-4d7796b7cf89
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 04, 2017