FDA.report

proGAV 2.0®

Primary DI
04041906140403
Brand
proGAV 2.0®
Company
Christoph Miethke GmbH & Co. KG
Model
FX363T
Catalog number
FX363T
Device description
PROGAV 2.0 WITH PRECHAMBER
Published
2015-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JXGShunt, central nervous system and components

Product Code Classifications

CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04041906140403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04041906140403040419061404034041906140403

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
343189676
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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04041906505622XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
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04041906505646XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
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04041906506681XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
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04041906506704XABOChristoph Miethke GmbH & Co. KGJXG2025-05-31
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