AccessGUDID - DEVICE: LiquoGuard 7 (04260277175788)

GUDID

Device Identifier (DI) Information

Brand Name: LiquoGuard 7
Version or Model: 00003500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Möller Medical GmbH

Primary DI Number: 04260277175788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320405061 *Terms of Use

Device Description: The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3- way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristaltic pump of LiquoGuard 7 whenever the current patient’s CSF pressure is higher than a preselected target pressure. Thus the LiquoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient’s mobility.

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?
59959	Cerebrospinal fluid pressure regulation system control unit/pump	A mains electricity (AC-powered) device, with a rechargeable battery, that is a component of a cerebrospinal fluid pressure regulation system designed to monitor/display cerebrospinal fluid (CSF) pressure, and to aspirate CSF at a rate regulated by CSF pressure, using a peristaltic pump. It is a software-controlled, electronic unit that is connected proximally to a disposable pressure sensor/tubing set and distally to a disposable collection set. It typically has a screen and controls to act as a user interface, and has alarms to signal when pressure measurements indicate possible complications (e.g., catheter occlusion, collapsed ventricle).	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 [?]
K150898	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: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 14 and 122 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5fc6bc80-5102-45df-a032-6815a207ab53
Public Version Date: January 10, 2022
Public Version Number: 2
DI Record Publish Date: October 31, 2018