M.blue Plus

FDA UDI

Class II (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name: M.BLUE PLUS FDA UDI
Generic Name: Ventriculo-peritoneal/atrial shunt FDA UDI
Device Name: M.BLUE PLUS SYS W/SPRUNG RESERVOIR FDA UDI
Model / Reference: FX844T FDA UDI
Description: M.BLUE PLUS SYS W/SPRUNG RESERVOIR FDA UDI

Identifiers

Catalog Number: FX844T FDA UDI
Primary DI / UDI-DI: 04041906504878 FDA UDI
510(k) Number: K192266 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ventriculo-peritoneal/atrial shunt

M.blue Plus by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ventriculo-peritoneal/atrial shunt.

OSV II® — Integra LifeSciences Switzerland Sàrl · Class II
Delta® — Medtronic PS Medical · Class II
Natus® — Natus Medical Incorporated · Class II
miniNAV® — Christoph Miethke GmbH & Co. KG · Class II
AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
CODMAN® HAKIM® — Integra LifeSciences Production Corporation · Class II
AESCULAP — Christoph Miethke GmbH & Co. KG · Class II
proGAV 2.0® — Christoph Miethke GmbH & Co. KG · Class II

Cleared under the same submission

K192266 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Aesculap, Inc.

Sources (1)

FDA UDI 74997806-439a-4fe4-b369-8bda3b608553 37 fields · synced Jun 6, 2026