AccessGUDID - DEVICE: Aqueduct SED (ACCBAG000)

GUDID

Device Identifier (DI) Information

Brand Name: Aqueduct SED
Version or Model: ACC-BAG-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AQUEDUCT CRITICAL CARE, INC.

Primary DI Number: ACCBAG000
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 Drain Bag interfaces with the Aqueduct SED Cartridge to collect CSF.

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?
59961	Cerebrospinal fluid pressure regulation system fluid-collection set	A sterile component of a cerebrospinal fluid pressure regulation system that consists of tubing and drainage bag designed to collect the cerebrospinal fluid (CSF) on the distal side of the CSF drainage control unit/pump, to which it is attached. It is typically made of synthetic polymer material. 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 [?]
K161605	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1526e8a-46b3-470e-b72b-24aa004d2737
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 20, 2017