FDA.reportPublic FDA data

proSA®

Primary DI
04041906139582
Brand
proSA®
Company
Christoph Miethke GmbH & Co. KG
Model
FV736T
Catalog number
FV736T
Device description
PROSA WITH PED.BURRHOLE RESERVOIR
Published
2015-11-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04041906139582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041906139582040419061395824041906139582

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculo-peritoneal/atrial shunt valveA sterile implantable device intended to function as part of a ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the 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 plastic and silicone materials. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
343189676
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04041906130107AESCULAPFV091PFV091P2021-03-09
04041906130053AESCULAPFV056TFV056T2015-09-24
04041906505622XABOFY012AFY012A2025-05-31
04041906505639XABOFY023AFY023A2025-05-31
04041906505646XABOFY044AFY044A2025-05-31
04041906506667XABOFY045AFY045A2025-05-31
04041906506674XABOFY010AFY010A2025-05-31
04041906506681XABOFY011AFY011A2025-05-31
04041906506698XABOFY020AFY020A2025-05-31
04041906506704XABOFY021AFY021A2025-05-31
04041906506711XABOFY022AFY022A2025-05-31
04041906506728XABOFY024AFY024A2025-05-31
04041906506735XABOFY025AFY025A2025-05-31
04041906506742XABOFY040AFY040A2025-05-31
04041906506759XABOFY041AFY041A2025-05-31
04041906506766XABOFY042AFY042A2025-05-31
04041906506773XABOFY043AFY043A2025-05-31
04041906130077AESCULAPFV058TFV058T2015-09-24
04041906130084AESCULAPFV059TFV059T2015-09-24
04041906029661proGAV®FV477TFV477T2021-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10381780537045CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537069CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
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10381780537144CODMAN® HAKIM® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537151CODMAN® BACTISEAL®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJXG2024-11-20
10381780537496Hermetic™Integra Lifesciences CorporationJXG2024-06-28
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10381780537489N/AIntegra Lifesciences CorporationJXG2024-06-21
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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