FDA.reportPublic FDA data

CODMAN HAKIM SIPHONGUARD

Primary DI
10886704041986
Brand
CODMAN HAKIM SIPHONGUARD
Company
Cerenovus, Inc.
Model
82-5464
Catalog number
825464
Device description
CODMAN HAKIM Precision Fixed Pressure Valve In-Line Valve with SIPHONGUARD Device Operating Pressure: 100mm H2O (980 Pa) Medium High Range Includes: Precision Valve, Information Manual and Priming Adapter
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K992173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992173000SIPHONGUARD CSF CONTROL DEVICEJohnson & Johnson Professionals, Inc.2000-04-07JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780520085PrimaryGS10
10886704041986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178052008510381780520085
1088670404198610886704041986

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid shunt valveAn implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Use if Package is Damaged

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704085324TRUFILL632400NA632400NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10381780537014CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537021CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537038CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537045CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537069CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537106CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537144CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537151CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537496Hermetic™Integra Lifesciences CorporationJXG2024-06-28
10381780538325CODMAN® VPV®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-06-28
10381780537489N/AIntegra Lifesciences CorporationJXG2024-06-21
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
10381780536840CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536864CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536901CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29
10381780536949CODMAN® ACCU-FLO®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-05-29