AccessGUDID - DEVICE: Drainage Set LiquoGuard US (04260277175962)

GUDID

Device Identifier (DI) Information

Brand Name: Drainage Set LiquoGuard US
Version or Model: 00003640
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Möller Medical GmbH

Primary DI Number: 04260277175962
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320405061 *Terms of Use

Device Description: The LiquoGuard CSF system is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbarsubarachnoid space in selected patients to reduce intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF systemn also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.

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?
59958	Cerebrospinal fluid pressure regulation system, peristaltic pump	An assembly of devices designed to simultaneously monitor cerebrospinal fluid (CSF) pressure and aspirate CSF at a rate regulated by the desired intracranial or in-tube CSF pressure. It is connected to a dedicated CSF access device (e.g., catheter, needle) inserted into the cerebral ventricles or subarachnoid (intrathecal) space of the spinal column. It consists of a mains electricity (AC-powered) control unit (and rechargeable battery) with a peristaltic pump and user interface; a disposable tubing set with integrated pressure sensor; and a disposable collection set. It is typically used in trauma, normal pressure hydrocephalus (NPH) diagnostics, and during major vascular surgery.	Active	false
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 [?]
K121248	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
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a06b2cd-248c-437f-966c-d6bb6ba019d8
Public Version Date: January 10, 2022
Public Version Number: 3
DI Record Publish Date: October 22, 2015