M.BLUE

Basic Information

• Brand Name: M.BLUE
• Primary DI: 04041906504427
• Version / Model: FX803T
• Catalog Number: FX803T
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-04
• Public Version: 3
• Public Version Date: 2021-12-10
• Public Version Status: Update
• Public Device Record Key: 6da06b0d-eedb-4c95-a4cd-a4516e1c7a33

Device Description

M.BLUE 15 VALVE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35965	Cerebrospinal fluid shunt valve	An 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04041906504427	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192266	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Pressure rating horiz. (cmH2O) : 15.000 CWS