FDA.report

GAV 2.0

Primary DI
04041906501303
Brand
GAV 2.0
Company
Aesculap AG
Model
FX250T
Catalog number
FX250T
Device description
GAV 2.0 SYST WITH CONTROL RES.10/25
Published
2020-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04041906501303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04041906501303040419065013034041906501303

GMDN Terms

TermDefinition
Ventriculo-peritoneal/atrial shuntA sterile implantable device intended to divert excessive cerebrospinal fluid (CSF) from the ventricles (fluid-filled cavities) of the brain to either the peritoneal cavity or the right atrium (i.e., dual-capability) where it can be absorbed into the body. It typically consists of a ventricular catheter, a mechanical shunt valve, and a distal catheter(s) that channels the CSF to the peritoneal cavity or right atrium. This device is intended as a therapeutic measure for situations where increased CSF causes increased intracranial pressure (hydrocephalus). Disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
315018218
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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