FDA.reportPublic FDA data

AESCULAP

Primary DI
04041906120405
Brand
AESCULAP
Company
Christoph Miethke GmbH & Co. KG
Model
FV077P
Catalog number
FV077P
Device description
"Ventricular Catheter marked, with mandrin, 9 3/4"" (250 mm), inner diam. 1,20 mm, outer diam. 2,50 mm, silicone, sterile, disposable"
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCACATHETER, VENTRICULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCACatheter, VentricularNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04041906120405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04041906120405040419061204054041906120405

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, long-termA sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
343189676
Device count
1
Lot or batch
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

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Primary DI, Brand, Company table
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