AccessGUDID - DEVICE: Aqueduct SED (ACCCART101)

GUDID

Device Identifier (DI) Information

Brand Name: Aqueduct SED
Version or Model: ACC-CART-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AQUEDUCT CRITICAL CARE, INC.

Primary DI Number: ACCCART101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 089176922 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
59960	Cerebrospinal fluid pressure regulation system sensor/tubing set	A sterile component of a cerebrospinal fluid pressure regulation system that consists of tubing and integrated mechanical pressure sensor designed to monitor cerebrospinal fluid (CSF) pressure to regulate drainage rate. It is intended to be taped to the patient?s skin at a specified level and connected proximally to a dedicated CSF access device ( e.g., catheter, needle), and distally to a CSF drainage control unit/pump. This is a single-use device.	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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