FDA.reportPublic FDA data

Drainage Set LiquoGuard 7

Primary DI
04260277176075
Brand
Drainage Set LiquoGuard 7
Company
Möller Medical GmbH
Model
00003501 2371
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 i
Published
2018-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
04260277176068PackageGS110In Commercial Distribution
04260277176075PackageGS160In Commercial Distribution
04260277176051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277176068042602771760684260277176068
04260277176075042602771760754260277176075
04260277176051042602771760514260277176051

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
04260277172855Breast localisation needleBLM-1110-20-00752018-08-17
04260277172879Breast localisation needleBLM-1110-20-01252018-08-17
04260277172930Breast localisation needleBLM-1120-20-00302018-08-17
04260277172947Breast localisation needleBLM-1120-20-00502018-08-17
04260277172954Breast localisation needleBLM-1120-20-00752018-08-17
04260277172961Breast localisation needleBLM-1120-20-01002018-08-17
04260277172978Breast localisation needleBLM-1120-20-01252018-08-17
04260277173036Breast localisation needleBLM-1130-20-00302018-08-17
04260277173043Breast localisation needleBLM-1130-20-00502018-08-17
04260277173050Breast localisation needleBLM-1130-20-00752018-08-17
04260277173067Breast localisation needleBLM-1130-20-01002018-08-17
04260277173074Breast localisation needleBLM-1130-20-01252018-08-17
04260277173654Breast localisation needleBLM-1125-20-00302018-08-17
04260277173661Breast localisation needleBLM-1125-20-00502018-08-17
04260277173678Breast localisation needleBLM-1125-20-00752018-08-17
04260277173685Breast localisation needleBLM-1125-20-01002018-08-17
04260277173692Breast localisation needleBLM-1125-20-01252018-08-17

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