FDA.reportPublic FDA data

Drainage Set LiquoGuard 7

Primary DI
04260277176020
Brand
Drainage Set LiquoGuard 7
Company
Möller Medical GmbH
Model
00003501 2351
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.
Published
2018-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150898000LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH2015-12-18JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277176037PackageGS110In Commercial Distribution
04260277176044PackageGS160In Commercial Distribution
04260277176020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277176037042602771760374260277176037
04260277176044042602771760444260277176044
04260277176020042602771760204260277176020

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid pressure regulation system sensor/tubing setA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Protect from direct sunlight
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
320405061
Device count
1
Lot or batch
true
Expiration date on label
true

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