FDA.reportPublic FDA data

Drainage Set LiquoGuard US

Primary DI
04260277175986
Brand
Drainage Set LiquoGuard US
Company
Möller Medical GmbH
Model
00003640
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 p
Published
2015-10-22
Public version status
Update
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
K121248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121248000LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTACMoller Medical GmbH2013-12-13JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277175979PackageGS110In Commercial Distribution
04260277175986PackageGS160In Commercial Distribution
04260277175962PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277175979042602771759794260277175979
04260277175986042602771759864260277175986
04260277175962042602771759624260277175962

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid pressure regulation system, peristaltic pumpAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
true
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
04260632793640TLA Tubing Liposat Pro plus000039972026-02-27
04260632794043TLA Tubing Liposat Pro plus000039972026-02-27
04260632792339TLA Tubing Liposat Pro plus000039972020-01-21
04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
04260632791622Basket Cannula 2.0ASC-R520-30-02502019-05-09
04260632791639Basket Cannula 2.0ASC-R520-30-03502019-05-09
04260632791646Basket Cannula 2.0ASC-R520-40-02502019-05-09
04260632791660Basket Cannula 2.0ASC-R520-50-02502019-05-09
04260632791677Basket Cannula 2.0ASC-R520-50-03502019-05-09
04260632791684Basket Cannula 2.0ASC-R521-30-02502019-05-09
04260632791691Basket Cannula 2.0ASC-R521-30-03502019-05-09
04260632791707Basket Cannula 2.0ASC-R521-40-02502019-05-09
04260632791721Basket Cannula 2.0ASC-R521-50-02502019-05-09
04260632790151Basket Cannula 2.0ASC-S520-40-03502019-05-06
04260632790168Basket Cannula 2.0ASC-S520-50-02502019-05-06
04260632790175Basket Cannula 2.0ASC-S520-50-03502019-05-06
04260632790182Basket Cannula 2.0ASC-S521-30-02502019-05-06
04260632790205Basket Cannula 2.0ASC-S521-40-02502019-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760409441121SophysaSOPHYSAJXG2026-06-05
03760409441138SophysaSOPHYSAJXG2026-06-05
03760409441145SophysaSOPHYSAJXG2026-06-05
03760409441152SophysaSOPHYSAJXG2026-06-05
03760409441169SophysaSOPHYSAJXG2026-06-05
03760409441176SophysaSOPHYSAJXG2026-06-05
03760409441183SophysaSOPHYSAJXG2026-06-05
03760409441190SophysaSOPHYSAJXG2026-06-05
03760409441206SophysaSOPHYSAJXG2026-06-05
03760409441213SophysaSOPHYSAJXG2026-06-05
03760409441220SophysaSOPHYSAJXG2026-06-05
03760409441237SophysaSOPHYSAJXG2026-06-05
03760409441244SophysaSOPHYSAJXG2026-06-05
03760409441251SophysaSOPHYSAJXG2026-06-05
03760409441268SophysaSOPHYSAJXG2026-06-05
10381780535362CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535379CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535881CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535928CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535942CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535393CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535430CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535829CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780535867CODMAN® CERTAS® PlusIntegra LifeSciences Switzerland SàrlJXG2024-11-20
10381780536734CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536741CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536758CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536765CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536789CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536819CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29