AccessGUDID - DEVICE: Aqueduct SED (ACCHLD100)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: ACCHLD100
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 Holder interfaces with the Aqueduct SED Drain Bag (ACCBAG000) when in use with the Aqueduct SED Console (ACCCON101).

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?
61952	Frame/rail/pole device holder	A clamp-like device intended to be affixed to a bed frame, standard rail or standing pole [e.g., intravenous (IV) pole] to provide a means to fix/mount a medical device (e.g., suction/irrigation pump, display monitor), or other non-medical device, to the support. It typically has a gripping profile that is compatible with the device it is intended to fit. This is a reusable 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: No
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: b8fb07bd-c31e-44dd-85ff-9af8cf25bc0e
Public Version Date: June 07, 2019
Public Version Number: 4
DI Record Publish Date: March 20, 2017