ReFlow Ventricular System

Primary DI
00860024001809
Brand
ReFlow Ventricular System
Company
Anuncia Medical, Inc.
Model
A0011
Device description
Ventricular Catheter and Flusher
Published
2018-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

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
K172006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172006000Alivio Ventricular Catheter and Flusher System (Alivio System)Alcyone Lifesciences, Inc.2017-11-09JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860024001816PackageGS12In Commercial Distribution
00860024001809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860024001816008600240018168600240018160860024001816
00860024001809008600240018098600240018090860024001809

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculo-peritoneal/atrial shuntAn implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to either the peritoneal cavity or the heart right atrium (i.e., dual-capability), where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It consists of: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal/atrial catheter that channels the CSF to the peritoneal cavity or right atrium; some types have a port/reservoir for hypodermic sampling/infusion. Disposable devices associated with implantation may be included.

Regulatory Flags#

DUNS number
081149501
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860024001847ReFlow Mini FlusherA022-1A022-12023-06-30

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