AccessGUDID - DEVICE: Drainage Set LiquoGuard 7 (04260277176082)

GUDID

Device Identifier (DI) Information

Brand Name: Drainage Set LiquoGuard 7
Version or Model: 00003501 2311
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Möller Medical GmbH

Primary DI Number: 04260277176082
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 tube set consists of a tubing, stop cocks with luer locks, a drainage bag with a reflux valve, adapters to ensure correct insertion into the pump, and a pressure sensor housing with two pressure transducers, a cable for connection to the pump and a sticker to attach the sensor housing to the patient's skin. The tube set is only for use with the LiquoGuard 7.

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 [?]
K150898	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
Special Storage Condition, Specify: Protect from direct sunlight
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf11377b-fb2f-462f-9138-0e92a57d7c7c
Public Version Date: January 10, 2022
Public Version Number: 2
DI Record Publish Date: October 31, 2018