ReFlow Ventricular System

FDA UDI

Class II (US FDA UDI)

by Anuncia Medical, Inc.

Identity

Trade Name: ReFlow Ventricular System FDA UDI
Generic Name: Ventriculo-peritoneal/atrial shunt FDA UDI
Device Name: Ventricular Catheter and Flusher FDA UDI
Model / Reference: A0011 FDA UDI
Description: Ventricular Catheter and Flusher FDA UDI

Identifiers

Primary DI / UDI-DI: 00860024001809 FDA UDI
510(k) Number: K172006 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Ventriculo-peritoneal/atrial shunt FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5550 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Ventriculo-peritoneal/atrial shunt

ReFlow Ventricular System by Anuncia Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Anuncia Medical, Inc.

Sources (1)

FDA UDI a57e96b9-f850-410f-97e0-5104ef24507d 34 fields · synced Jun 8, 2026